Research & Clinical Trials

Advanced Solid Tumors

(Read more) Abbvie Protocol M16-438 - A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Anti-Tumor Activity ofABBV-321 in Subjects with Advanced Solid Tumors Associated with Overexpression of the Epidermal Growth Factor Receptor (EGFR) or its Ligands
Summary: This is an open-label, Phase 1, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-321 for participants with advanced solid tumors likely to overexpress the epidermal growth factor receptor (EGFR). The study will consist of 2 phases: Dose Escalation Phase and Expansion Phase.

(Read more) Agenus Protocol C-800-01 - A phase 1 study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer
Summary: This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.
Condition/Disease: Breast Cancer, Ovarian Cancer, Sarcoma, Endometrial Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma
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(Read more) Alkermes Artistry-2 Protocol ALKS 4230-001 - A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination with Pembrolizumab in Subjects With Advanced Solid Tumors- ARTISTRY-2 (001)
Summary: This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.
Condition/Disease: Advanced Solid Tumors
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(Read more) Arcus Protocol AB154CSP0001 - A phase 1 study to evaluate the safety and tolerability of AB154 monotherapy and combination therapy in participants with advance malignancies
Summary: This is a Phase 1, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, PK, PD, and clinical activity of domvanalimab (AB154) as monotherapy and in combination with zimberelimab (AB122) in participants with advanced solid malignancies.
Condition/Disease: Advanced Solid Tumors
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(Read more) Arcus Protocol AB680CSP00902 - A Phase 1 Study to Evaluate the Safety and Tolerability of AB680 Combination Therapy in Participants with Gastrointestinal Malignancies tumors
Summary: This is a Phase 1, open-label, dose-escalation, and dose-expansion, with a gated randomization portion, study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and clinical activity of AB680 in combination with Zimberelimab (AB122), nab-paclitaxel and gemcitabine in participants with advanced pancreatic cancer.
Condition/Disease: Pancreatic Cancer
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(Read more) Arcus Protocol AB928CSP0005 - A Phase 1 Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Advanced Malignancies
Summary: This is a Phase 1, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity of AB928 in combination with AB122 (an anti-PD-1 antibody) in participants with advanced malignancies.

(Read more) Astellas Protocol 9801-CL-0101 - A phase 1, open-label study of ASP9801, an oncolytic virus, administered by intratumoral injection in patients with advanced/metastatic solid tumors
Summary: The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801 as a single agent, as well as in combination with pembrolizumab, an anti-programmed cell death protein 1 (PD-1) checkpoint inhibitor.
Condition/Disease: Advanced Solid Tumors
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(Read more) AstraZeneca Protocol D8151C00001 - A phase II study to evaluate the safety, pharmaco kinetics, and clinical activity of AZD0171 in combination with durvalumab and chemotherapy in participants with locally advanced or metastatic solid tumors
Summary: The proposed study is designed to examine the effects of AZD0171 and durvalumab in combination with standard-of-care chemotherapy in patients with pancreatic ductal adenocarcinoma (PDAC).
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
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(Read more) Bayer Protocol 19769 - An open-label, multi-center, phase 1b/2 study to evaluate the safety and efficacy of copanlisib in combination with nivolumab in patients with advanced solid tumors
Summary: The purpose of the dose escalation part of this study is to determine the feasibility of using the combination of copanlisib and nivolumab in subjects with advanced solid tumors, and to determine the maximum tolerated dose of copanlisib in combination with nivolumab. The maximum tolerated dose will then be used in Phase 2 (dose expansion) of the study.

(Read more) Bioatla Protocol BA3071-001 - A phase ½ study of BA3071 in combination with NIVOLUMAB IN PATIENTS WITH ADVANCED SOLID TUMORS
Summary: The objective of this study is to assess safety and efficacy of BA3071 in solid tumors.
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
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(Read more) Biontech Protocol MV-0715-CP-001.01 - Phase 1 safety and tolerability study fo human monoclonal antibody 5B1(MVT-5873) with expansion in subjects with pancreatic cancer or other CA19-9 positive malignancies
Summary: Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.
Condition/Disease: Pancreatic Cancer
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(Read more) BMS Protocol CA111-001 - A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants with Advanced Malignant Tumors
Summary: The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone and in combination with nivolumab in participants with advanced tumors.
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
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(Read more) BMS Protocol IM043-004 - A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination with Chemotherapy or Nivolumab in Advanced Solid Tumors
Condition/Disease: Breast Cancer, Sarcoma, Colon Cancer, Pancreatic Cancer, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma

(Read more) CytomX Protocol CTMX-M-072-001 - An open-label, dose-finding and proof of concept study of the pd-l1 probodytm therapeutic, cx-072, as monotherapy and in combination with yervoy® (ipilimumab) or with zelboraf® (vemurafenib) in subjects with advanced or recurrent solid tumors or lymphomas
Summary: The purpose of this first-in-human study of CX-072 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072 administered intravenously (IV) as a single agent or in combination with ipilimumab or vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas. PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial. CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1). Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the therapeutic index by minimizing drug interaction with normal tissue while retaining anti-tumor activity. Probody therapeutics are "masked" to attenuate binding to target in healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific protease activity. PROBODY is a trademark of CytomX Therapeutics, Inc.

(Read more) CytomX Protocol CTMX-M-072-002 - A Phase 2, open-label, multi-cohort study of PD-L1 probody therapeutic CX 072 in combination with other anticancer therapy in adults with solid tumors
Summary: To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST).

(Read more) DayOne Protocol DAY101-102 - A phase 1b/2, open label study of DAY101 monotherapy or combination with other therapies for patients with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations
Summary: This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent or progressive solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Lung Cancer - Non-Small Cell
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(Read more) DZ002 - A Pharmacokinetic and Pharmacodynamic Study of DZ-002 in Patients With Advanced Solid Malignancies or Lymphoma
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
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(Read more) ENB Therapeutics Protocol ENB-003 - A phase 1/2A trial of ENB 003 in combination with pembrolizumab in subjects with advanced solid tumors
Summary: First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.
Condition/Disease: Ovarian Cancer, Melanoma - Metastatic Melanoma, Sarcoma, Pancreatic Cancer
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(Read more) Endocrine Marker - Prospective study of predictive markers and changes in specific endocrine hormones in patients with metastatic cancers treated with immune checkpoint inhibitors

(Read more) Exelixis Protocol XB002-101 - A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Summary: This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with nivolumab or bevacizumab to subjects with advanced solid tumors.
Condition/Disease: Ovarian Cancer, Pancreatic Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell
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(Read more) Exelixis Protocol XL092-001 - A dose -escalation and expansion study of the safety and pharmacokinetics of XL092 as single-agent and combination therapy in subject with inoperable locally advanced or metastatic solid tumors
Summary: This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.
Condition/Disease: Renal Cell Carcinoma
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(Read more) Exelixis Protocol XL184-021 - A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors
Summary: This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer/gastroesophageal junction cancer/lower esophageal cancer (GC/GEJC/LEC), colorectal cancer (CRC), head and neck (H&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of this study design, some tumor cohorts may complete enrollment earlier than others.

(Read more) GSK Protocol 204691 - A phase 1 open label study of GSK3359609 administered alone and in combination with anticancer agents in subjects with select advanced solid tumors
Summary: GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in subjects with advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.

(Read more) GSK Protocol 212214 - A Phase 1 First-Time-in-Human, Open-Label Study of GSK6097608 Administered as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Tumors
Summary: This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy and in combination with GSK6097608 and with GSK4428859A (EOS884448) in Japanese and Chinese participants. Drug name mentioned as GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as GSK4428859A (EOS884448).
Condition/Disease: Endometrial Cancer
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(Read more) IIT2019-20-Zumsteg-HPVOPC - Phase II Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer
Condition/Disease: Head and Neck Cancer

(Read more) Immunocore Protocol IMC-C103-101 - A phase ½ first-in-human study of the safety and efficacy of IMC-C103C as a single agent and in combination with atezolizumab in HLA-A 0201-positive patients with advanced mage-A4- positive cancer
Summary: IMC-C103C is an immune mobilizing T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen MAGE-A4. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-C103C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for MAGE-A4.
The IMC-C103C-101 Phase 1/2 study will be evaluated in patients with metastatic/unresectable tumors which include select Advanced Solid Tumors and will be conducted in two phases.
1. To identify the MTD and/or RP2D of IMC-C103C as a single agent administered Q1W (Arm A1) and administered Q1W in combination with Q3W atezolizumab (Arm A2).
2. To assess the preliminary anti-tumor activity of IMC C103C in one or more selected indications, as a single agent administered Q1W (Arm B1) and administered Q1W in combination with Q3W atezolizumab (Arm B2).

(Read more) Immunocore Protocol IMC-F106C-101 - A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers Melanoma
Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Condition/Disease: Breast Cancer, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Sarcoma, Bladder Cancer, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Lung Cancer - Non-Small Cell
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(Read more) Incyte Protocol INCA 0186-101 - A phase 1, open-label, multicenter study of INCA00186 as monotherapy or in combination with immunotherapy in participants with advanced solid tumors
Summary: This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Pancreatic Cancer, Phase I Clinical Trials
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(Read more) Incyte Protocol INCA32459-101 - Incyte LAG3xPD-1 study - A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants With Select Advanced Malignancies
Condition/Disease: Advanced Solid Tumors

(Read more) Incyte Protocol INCAGN 2385-201 - A phase 1-2 study of combination therapy with INCMGA00012(Anti-PD-1), INCAGN02385(Anti-LAG-3), and INCAGN02390(Anti-TIM-3) in participants with select advanced malignancies
Summary: The study will determine Recommended Phase 2 Dose for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012.
Condition/Disease: Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials
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(Read more) Incyte Protocol INCAGN 2390-101 - A phase 1, open-label, dose-escalation, safety and tolerability study of INCAGN02390 in participants with select advanced malignancies
Summary: The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.

(Read more) Incyte Protocol INCMGA 0012-102 - A phase 1b study of INCMGA00012 in combination with other therapies in patients with advanced solid tumors
Summary: The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.

(Read more) Innovent Protocol CIBI322A102 - A phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors
Summary: This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.
Condition/Disease: Advanced Solid Tumors
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(Read more) Iovance Protocol IOV-GM1-201 - A Phase 1/2, open-label study of PD-1 knockout tumor-infiltrating lymphocytes (IOV-4001) in participants with unresectable or metastatic melanoma or Stage III or IV non-small-cell lung cancer
Summary: This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) KZR-261-101 - A Phase1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects with Advanced Solid Malignancies
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Mesothelioma, Prostate Cancer

(Read more) Leap Protocol DEK-DKK1-P205 - A Phase 2a, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (DisTinGuish)
Summary: A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma.
Condition/Disease: Gastric Cancer, Esophageal Cancer
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(Read more) Mereo Protocol MPH313-1-02 - A phase 1b/2 open-label study of the efficacy and safety of Etigilimab(MPH313) administered in combination with Nivolumab to subjects with locally advanced or metastatic solid tumors
Summary: This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors. Subjects will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks).
Condition/Disease: Advanced Solid Tumors
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(Read more) NextCure Protocol NC318-01 - A Phase ½ open-label, dose-escalation, safety and tolerability study of NC318 in subjects with Advanced or Metastatic Solid Tumors
Summary: This research study is studying a new drug, NC318, as a possible treatment for advanced or metastatic solid tumors.

(Read more) NGM Bio Protocol 831-IO-101 - A Phase 1/1b dose escalation /expansion study of NGM831 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors
Summary: Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma - Metastatic Melanoma, Pancreatic Cancer, Phase I Clinical Trials, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma
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(Read more) Novartis daNIS-3 Protocol CNIS793E12201 - An open-label, multi-center, phase II platform study evaluating the efficacy and safety of NIS793 and other new investigational drug combinations with standard of care (SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer (mCRC)
Summary: The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793 and other novel investigational combinations with standard of care (SOC) anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of mCRC. This study aims to explore whether different mechanisms of action may reverse resistance and improve responsiveness to the currently considered SOC anti-cancer therapy in the second line metastatic colorectal cancer (mCRC) setting.
Condition/Disease: Colorectal Cancer
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(Read more) Pfizer Protocol C4401001 - A phase 1 dose escalation and expansion study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07257876 in patients with advanced or metastatic tumors
Summary: This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic and potential clinical benefit of PF-07257876, a CD47-PD-L1 bispecific antibody, in participants with selected advanced or metastatic tumors for whom no standard therapy is available. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07257876, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
Condition/Disease: Head and Neck Cancer, Lung Cancer - Non-Small Cell
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(Read more) Regeneron Protocol R2810-ONC-1788 - A randomized, placebo-controlled, double-blind study of adjuvant cemiplimab versus placebo after surgery and radiation therapy in patients with high risk cutaneous squamous cell carcinoma. TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT).
The secondary objectives of the study are:
• To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT
• To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT
• To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT
• To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT
• To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT

(Read more) Regeneron Protocol R3767-ONC-1613 - A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (anti-LAG-3 mAb) Administered Alone or in Combination with REGN2810 (anti-PD-1 mAb) in Patients with Advanced Malignancies
Summary: The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma. The primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (ORR).

(Read more) Regeneron Protocol R3767-ONC-2011 - A phase 3 trial of FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA
Summary: The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS)
The secondary objectives of the study are:
-To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS)
-To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab
-To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component
-To assess immunogenicity of fianlimab and cemiplimab
-To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults
-To characterize safety and tolerability of treatment in patients 12 to <18 years of age
-To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age
-To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab
-To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) Regeneron Protocol R6569-ONC-1933 - A phase 1 study of REGN6569, an anti-GITR mAb, with cemiplimab in patients with advanced solid tumor malignancies
Summary: For dose escalation cohorts, the primary objective is to evaluate the safety and tolerability of REGN6569 as monotherapy lead-in and in combination with cemiplimab.
For dose expansion cohorts, the co-primary objectives are:
-To assess the preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by objective response rate (ORR)
-To assess the preliminary pharmacodynamic activity of REGN6569 as lead-in monotherapy, as measured by intratumoral Glucocorticoid-Induced Tumor necrosis factor receptor-Related (GITR)+ Treg depletion
Secondary Objectives are:
For dose escalation cohorts:
-To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by ORR, disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS)
-To characterize the pharmacokinetics (PK) of REGN6569 alone and in combination with cemiplimab
-To assess the immunogenicity of REGN6569 and cemiplimab
For expansion cohorts:
-To characterize the safety profile in each expansion cohort
-To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by DCR, DOR, PFS, and OS
-To characterize the PK of REGN6569 alone and in combination with cemiplimab
-To assess the immunogenicity of REGN6569 and cemiplimab
Condition/Disease: Squamous Cell Cancer Skin
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(Read more) Seagen Protocol SGNS40-002 - An open-label, phase 2 basket study of SEA-CD40 combination therapies in advanced malignancies.
Summary: This trial is being done to see if an experimental drug (SEA-CD40) works when it's given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug.
There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can't be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed.
Condition/Disease: Melanoma, Lung Cancer - Non-Small Cell
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(Read more) Seattle Genetics Protocol SGN228-001 - A phase 1 study of SGN-CD228A in select advanced solid tumors
Summary: This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.
Condition/Disease: Pancreatic Cancer, Lung Cancer - Non-Small Cell
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(Read more) Seattle Genetics Protocol SGNSTNV-001 - A study of SGN-STNV in advanced solid tumors
Summary: This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Phase I Clinical Trials, Endometrial Cancer, Lung Cancer - Non-Small Cell
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(Read more) Seattle Genetics SGN35-33 - A phase 2 study of brentuximab vedotin in combination with pembrolizumab in subjects with metastatic solid malignancies after progression on prior PD-1 inhibitor treatment
Summary: This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic).
The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer.
This is a multi-cohort study.
Condition/Disease: Melanoma - Metastatic Melanoma, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Melanoma – Adjuvant Therapy
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(Read more) Shionogi Protocol 2023P2411 - A phase 1b/2, multicenter, open-label study of S-531011 as monotherapy and in combination with an immune checkpoint inhibitor in participants with locally advanced or metastatic solid tumors
Summary: The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011.
The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D.
Condition/Disease: Advanced Solid Tumors
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(Read more) Takeda Protocol TAK-573-1001 - An Open-Label, Dose-Escalation Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-573 as a Single Agent and in Combination with Pembrolizumab in Adult Patients with Metastatic Solid Tumors
Summary: This study has 2 phases.
The main aims of Phase 1b are:
-to check for side effects from modakafusp alfa in adults with locally advanced or metastatic solid tumors.
-to learn how much modakafusp alfa adults can receive without getting any major side effects from it.
The main aims of Phase 2 are:
-to check for side effects from modakafusp alfa when given together with pembrolizumab in adults with metastatic cutaneous melanoma which cannot be completely removed by surgery.
-to learn how these medicines improve their symptoms.
Participants will receive modakafusp alfa for up to 1 year (Phase 1b) or modakafusp alfa given together with pembrolizumab for up to 2 years (Phase 2). Those whose symptoms improve might continue treatment for longer.
In both phases of the study, participants will revisit the study clinic within 30 days after their last dose or before they start other cancer treatment, whichever happens first.
Condition/Disease: Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials
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(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Tmunity Protocol CART-TnMUC1-01 - A phase 1, open-label, multi-center first in human study of TnMUC1-Targeted genetically-modified chimeric antigen receptor T cells in patients with advanced TnMUC1-positive solid tumors and multiple myeloma
Summary: Multi-center, open-label, first in human Phase 1 study of the safety, tolerability, feasibility, and preliminary efficacy of the administration of genetically modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells).
Condition/Disease: Ovarian Cancer, Lung Cancer - Non-Small Cell
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(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
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(Read more) TyrNovo Protocol TYR-219-01 - A Phase 1/2 Study with Open-Label, Dose Escalation Phase Followed by Single-Arm Expansion at the Maximum Tolerated Dose to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of NT219 Injection alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced solid tumors and Head and Neck cancer
Summary: This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials, Head and Neck Cancer
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(Read more) XL092-001 - A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Condition/Disease: Breast Cancer, Colon Cancer, Phase I Clinical Trials, Renal Cell Carcinoma, Prostate Cancer

Common

(Read more) Astellas Protocol 8951-CL-0103 - A Phase 2 Study of IMAB362 as Monotherapy or in Combination with mFOLFOX6 in Subjects with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma whose Tumors have High or Intermediate Claudin (CLDN) 18.2 Expression
Summary: The purpose of this study is to determine the Objective Response Rate (ORR) of zolbetuzimab as a single agent as assessed by an independent central reader. This study will also assess the ORR and Progression Free Survival (PFS) of zolbetuximab in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab, assess the safety and tolerability, assess the effects on CLDN18.2 expression and assess the immunogenicity and immunomodulatory effects of zolbetuximab as a single agent and in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab. This study will also evaluate the pharmacokinetics (PK) of zolbetuximab, oxaliplatin, fluorouracil (5-FU), and pembrolizumab, evaluate health-Related Quality of Life (HRQoL), evaluate the Disease Control Rate (DCR), Duration of Response (DOR), PFS of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab based on both investigator and independent central reader assessment, assess Overall Survival (OS) of zolbetuximab as a single agent and in combination with pembrolizumab.
Condition/Disease: Gastric Cancer
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Lung Cancer

(Read more) IIT2021-12-Reckamp-Osi105 - Phase 1 Study of Osimertinib with Carotuximab in Advanced, EGFR-mutated Non-small Cell Lung Cancer
Condition/Disease: Lung Cancer - Non-Small Cell
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Melanoma

(Read more) Alkermes Artistry-6 Protocol ALKS 4230-006 - A Phase 2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy in patients with advanced melanoma who have previously received anti-PDL1 therapy
Summary: This study observes the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) Array Protocol ARRAY-818-201 - A phase 2 open-label, randomized, multi-center trial of Encorafenib + Binimetinib evaluating a standard-dose and a high-dose regimen in patients with BRAFV600-mutant melanoma brain metastasis
Summary: This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a Screening Period, treatment will be administered in 28-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent anticancer therapy, death.

(Read more) BMS Protocol CA224-098 - Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versusNivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma (RELATIVITY 098)
Summary: The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
Condition/Disease: Melanoma
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(Read more) BMS Protocol CA224-127 - A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed dose Combination versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants with Previously Untreated Metastatic or Unresectable Melanoma
Condition/Disease: Melanoma - Metastatic Melanoma

(Read more) EA6192 - A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop)
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) Foghorn Protocol FHD-286-C-001 - A phase 1, multicenter, open-label, dose escalation and expansion study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered FHD-286 in subjects with metastatic uveal melanoma
Summary: This Phase 1, multicenter, open-label, dose escalation and expansion study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 oral monotherapy in subjects with metastatic Uveal Melanoma (UM).
Condition/Disease: Melanoma - Ocular Melanoma
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(Read more) Genentech Protocol GO40558 - A phase 2, open-label, multi-center, randomized study of the efficacy and safety of RO7198457 in combination with pembrolizumab versus pembrolizumab in patients with previously untreated advanced melanoma
Summary: This study will evaluate the efficacy, safety, pharmacokinetics, and patient-reported outcomes (PROs) of RO7198457 plus pembrolizumab compared with pembrolizumab alone in patients with previously untreated advanced melanoma.

(Read more) Honor Health Protocol TTFIELDS-UM - First in Human Early Feasibility Study of Tumor-Treating Fields in Combination with Nivolumab and Ipilimumab in Metastatic Uveal Melanoma
Summary: Tumor Treating Fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.
Condition/Disease: Melanoma - Ocular Melanoma
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(Read more) Immunocore Protocol IMCgp100-201 - A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in Combination with Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab Compared to IMCgp100 Alone in Patients with Advanced Melanoma
Summary: This study is a Phase Ib/II, multi-center, open-label study of tebentafusp (IMCgp100) as a single agent and in combination with durvalumab (MEDI4736) and/or tremelimumab in metastatic cutaneous melanoma. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and to evaluate the anti-tumor activity of tebentafusp (IMCgp100) in combination with durvalumab (MEDI4736, programmed death-ligand 1 [PD-L1] inhibitor), tremelimumab (CLTA-4 inhibitor), and the combination of durvalumab with tremelimumab compared to single-agent tebentafusp (IMCgp100) alone. The study will enroll patients who have metastatic melanoma that is refractory to treatment with an anti-PD-1 inhibitor in the metastatic setting. This study will also evaluate the safety, tolerability, and anti-tumor activity of tebentafusp (IMCgp100) monotherapy in patients with advanced non-uveal melanoma who progressed on prior PD-1 inhibitors approved for the treatment of advanced melanoma; patients with BRAF mutations must be refractory to approved BRAF-based therapy.
Recent biologic evidence indicates that optimal responses to programmed cell death-1 (PD-1) directed therapy require the presence of CD8+ T cells in the tumor microenvironment and thus therapies such as tebentafusp (IMCgp100) that recruit these effector cells to the tumor may overcome pre-existing resistance to checkpoint blockade. This emerging biology of checkpoint inhibitor resistance suggests the combination of tebentafusp (IMCgp100) with checkpoint inhibition may have enhanced activity in patients with pre-existing resistance.
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) Immunocore Protocol IMCgp100-202 - A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma
Summary: To evaluate the overall survival of HLA-A*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab. Detailed Description: This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A*0201 positive adult patients with advanced UM treated in the first line setting with no prior systemic or liver-directed chemo-, radio- or immune-therapy administered in the advanced setting (prior surgical resection of liver metastases and adjuvant systemic therapy are acceptable). Comparison of the IMCgp100 efficacy results in this Phase II study will be made with the concurrently randomized arm (Investigator's Choice) with a primary endpoint of overall survival (OS) and secondary efficacy endpoints of progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and disease control rate (DCR).

(Read more) Instil Bio ITIL-168-101 / ITLUTM01-UTM001 - A Phase 2, Open-label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects with Advanced Melanoma
Summary: DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).
Condition/Disease: Melanoma
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(Read more) KZR-261-101 - A Phase1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects with Advanced Solid Malignancies
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Mesothelioma, Prostate Cancer

(Read more) Lokon Protocol LOKON003 - A Phase I/II Trial Investigating LOAd703 in Combination with Atezolizumab in Malignant Melanoma
Summary: This study aims to evaluate safety and effect of combining an oncolytic adenovirus (delolimogene mupadenorepvec; LOAd703) with atezolizumab in patients with melanoma. LOAd703 will be administered intratumorally for up to 12 injections while atezolizumab will be administered intravenously for the duration of the active study visits (up to 57 weeks). The patients are then monitored for survival for maximum study participation of 48 months. The treatments will be given every 3 weeks. The patients will then be monitored for toxicity, PK, ADA, immune responses, virus shedding, tumor response by RECIST 1.1 and survival.
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) Merck 7684A-010 - A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab with Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants with High-risk Stage II-IV Melanoma (KEYVIBE-010)
Condition/Disease: Melanoma – Adjuvant Therapy
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(Read more) Merck Protocol MK-3475-U02 - This trial is a multicenter phase 1/2 open-label rolling arm platform design of investigational agents with or without pembrolizumab or pembrolizumab alone in participants with Melanoma
Summary: Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.
The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.
Condition/Disease: Melanoma
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(Read more) Merck Protocol MK-3475-U02-01 - A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma: Master (KEYNOTE-U02)
Condition/Disease: Melanoma - Metastatic Melanoma, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases
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(Read more) Merck Protocol MK-7902-003-01 - A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants with Advanced Melanoma (LEAP-003)
Summary: The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advance melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

(Read more) Merck Protocol MK3475-716 - An Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE 716)
Summary: This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Participants who receive placebo or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1, do not experience disease recurrence within 6 months of completing pembrolizumab in Part 1, and do not stop treatment with pembrolizumab for disease recurrence or intolerability, may be eligible to receive up to 35 additional cycles of pembrolizumab in Part 2 in an open-label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo.

(Read more) Moderna Protocol mRNA-4157-P201 - A phase 2 randomized study of adjuvant immunotherapy with the personalized cancer vaccine mRNA-4157 and pembrolizumab versus pembrolizumab alone after complete resection of high-risk melanoma
Summary: The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in patients with complete resection of cutaneous melanoma and a high risk of recurrence.
Condition/Disease: Melanoma – Adjuvant Therapy

(Read more) NKI CA209-6FR/M21NDN (NADINA) - Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab in macroscopic stage III melanoma – NADINA
Condition/Disease: Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy
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(Read more) Novartis Protocol CPDR001J2201 - A randomized, open-label, phase II open platform study evaluating the efficacy and safety of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma
Summary: The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma.
Condition/Disease: Melanoma
Intervention: Drug: Spartalizumab
Drug: LAG525
Drug: Capmatinib
Drug: Canakinumab
Drug: Ribociclib

(Read more) NYU EIITS22-00325 - A Phase II Study of the Interleukin-6 Receptor Blocking Antibody Sarilumab in Combination with Ipilimumab, Nivolumab and Relatlimab in Patients with Unresectable Stage III or Stage IV Melanoma
Summary: The study will evaluate how safe the study drug is, how well you tolerate it, and how it works in the body and the disease's response to the drug. The study drug being tested is sarilumab, when given with the combination of ipilimumab, nivolumab, and relatlimab in patients with stage III or stage IV melanoma that cannot be removed by surgery. Previous studies have provided a strong rationale for combining sarilumab, with ipilimumab, nivolumab and relatlimab in metastatic melanoma to reduce side effects and potentially work better for this type of cancer. Sarilumab is an FDA-approved inhibitor of the receptor for the cytokine IL-6, currently approved for the treatment of rheumatoid arthritis, but it is not FDA-approved to treat melanoma. This means that the use of Sarilumab to treat melanoma is considered investigational. The other drugs which will be administered in this study, ipilimumab and nivolumab, are also monoclonal antibodies, but they target different proteins. Ipilimumab and nivolumab are both approved by the FDA to treat advanced stage III and IV melanomas. The nivolumab + relatlimab FDC (fixed dose combination) being used in this study is considered investigational, meaning it is not approved by the FDA.
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) NYU S19-00008/BMS CA209-76Y - A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination with Ipilimumab and Nivolumab in Patients with Unresectable Stage III or Stage IV Melanoma
Summary: This is a Phase II, open-label, single arm study. The study will consist of an assessment of the safety and tolerability of tocilizumab administered concurrently at 4 mg/kg every 6 weeks for 5 doses in combination with ipilimumab and nivolumab for four induction doses to week 12, then maintenance nivolumab alone up to one year to patients with advanced melanoma. Treatment will be divided into induction and maintenance phases. It is anticipated that this clinical study will inform the use of this 3-drug combination for further phase II and/or phase III clinical testing. The trial will include an assessment of the pharmacodynamic activity of tocilizumab administered in combination with ipilimumab and nivolumab.
Condition/Disease: Melanoma
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(Read more) Parker Institute Protocol PICI0014 - A Multicenter Phase 1b Randomized, Placebo-controlled, Blinded Study to Evaluate the Safety, Tolerability and Efficacy of Microbiome Study Intervention Administration in Combination with Anti-PD-1 Therapy in Adult Patients with Unresectable or Metastatic Melanoma
Summary: This study is designed to evaluate the safety and tolerability of treatment with oral microbiome study intervention (SER-401) or matching placebo in combination with anti-programmed cell death 1 (anti-PD-1) therapy (nivolumab) in participants with unresectable or metastatic melanoma. The study also intends to assess clinical outcomes, the impact of microbiome study intervention administration on the microbiome profile, and its association with clinical and immunological outcomes.
Condition/Disease: Melanoma
Intervention: Drug: Placebo for antibiotic
Drug: Vancomycin pretreatment
Drug: Nivolumab
Drug: Matching Placebo for SER-401
Drug: SER-401
Phase 1: This is a Phase 1b, multicenter, randomized, placebo-controlled, blinded study in adult participants with anti-PD-1 therapy naïve, unresectable or metastatic melanoma to evaluate the safety and tolerability of SER-401, or matching placebo in combination with anti-PD-1 therapy (nivolumab). Prior to initiating microbiome study intervention and nivolumab, participants will undergo an antibiotic or antibiotic placebo treatment lead-in to prime the gut microbiome for engraftment of the oral microbiome study intervention. Study intervention groups will be assessed for safety, changes in the microbiome, changes in the percentage of tumoral CD8 T cells, and antitumor activity. Participants must have measurable disease that can be biopsied and consent to baseline and on-treatment biopsies, as well as stool and blood biomarker collection throughout the study.

(Read more) Substudy 02A - Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) Substudy 02B - Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) Substudy 02C - Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)
Condition/Disease: Melanoma – NeoAdjuvant Therapy
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(Read more) Substudy 02D - Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02)
Condition/Disease: Melanoma – Brain Metastases
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Advanced Solid Tumors

(Read more) Alkermes Artistry-2 Protocol ALKS 4230-001 - A Phase 1/2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy and in Combination with Pembrolizumab in Subjects With Advanced Solid Tumors- ARTISTRY-2 (001)
Summary: This study will characterize the safety and tolerability and identify the recommended Phase 2 dose (RP2D) of subcutaneous (SC) ALKS 4230 as monotherapy and in combination with pembrolizumab.
Condition/Disease: Advanced Solid Tumors
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(Read more) Arcus Protocol AB154CSP0001 - A phase 1 study to evaluate the safety and tolerability of AB154 monotherapy and combination therapy in participants with advance malignancies
Summary: This is a Phase 1, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, PK, PD, and clinical activity of domvanalimab (AB154) as monotherapy and in combination with zimberelimab (AB122) in participants with advanced solid malignancies.
Condition/Disease: Advanced Solid Tumors
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(Read more) Astellas Protocol 9801-CL-0101 - A phase 1, open-label study of ASP9801, an oncolytic virus, administered by intratumoral injection in patients with advanced/metastatic solid tumors
Summary: The purpose of this study is to assess the safety and tolerability of ASP9801 and to determine the recommended phase 2 dose (RP2D). The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of ASP9801 as a single agent, as well as in combination with pembrolizumab, an anti-programmed cell death protein 1 (PD-1) checkpoint inhibitor.
Condition/Disease: Advanced Solid Tumors
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(Read more) AstraZeneca Protocol D8151C00001 - A phase II study to evaluate the safety, pharmaco kinetics, and clinical activity of AZD0171 in combination with durvalumab and chemotherapy in participants with locally advanced or metastatic solid tumors
Summary: The proposed study is designed to examine the effects of AZD0171 and durvalumab in combination with standard-of-care chemotherapy in patients with pancreatic ductal adenocarcinoma (PDAC).
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
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(Read more) Bioatla Protocol BA3071-001 - A phase ½ study of BA3071 in combination with NIVOLUMAB IN PATIENTS WITH ADVANCED SOLID TUMORS
Summary: The objective of this study is to assess safety and efficacy of BA3071 in solid tumors.
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
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(Read more) BMS Protocol CA111-001 - A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants with Advanced Malignant Tumors
Summary: The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone and in combination with nivolumab in participants with advanced tumors.
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
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(Read more) DayOne Protocol DAY101-102 - A phase 1b/2, open label study of DAY101 monotherapy or combination with other therapies for patients with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations
Summary: This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent or progressive solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Lung Cancer - Non-Small Cell
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(Read more) DZ002 - A Pharmacokinetic and Pharmacodynamic Study of DZ-002 in Patients With Advanced Solid Malignancies or Lymphoma
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
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(Read more) Incyte Protocol INCA 0186-101 - A phase 1, open-label, multicenter study of INCA00186 as monotherapy or in combination with immunotherapy in participants with advanced solid tumors
Summary: This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Pancreatic Cancer, Phase I Clinical Trials
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(Read more) Incyte Protocol INCA32459-101 - Incyte LAG3xPD-1 study - A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants With Select Advanced Malignancies
Condition/Disease: Advanced Solid Tumors

(Read more) Incyte Protocol INCAGN 2385-201 - A phase 1-2 study of combination therapy with INCMGA00012(Anti-PD-1), INCAGN02385(Anti-LAG-3), and INCAGN02390(Anti-TIM-3) in participants with select advanced malignancies
Summary: The study will determine Recommended Phase 2 Dose for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012.
Condition/Disease: Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials
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(Read more) Innovent Protocol CIBI322A102 - A phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors
Summary: This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.
Condition/Disease: Advanced Solid Tumors
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(Read more) KZR-261-101 - A Phase1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects with Advanced Solid Malignancies
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Mesothelioma, Prostate Cancer

(Read more) Mereo Protocol MPH313-1-02 - A phase 1b/2 open-label study of the efficacy and safety of Etigilimab(MPH313) administered in combination with Nivolumab to subjects with locally advanced or metastatic solid tumors
Summary: This is an open-label, phase 1b/2, multicenter study designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab in combination with nivolumab in subjects with locally advanced or metastatic solid tumors. Subjects will be assigned to receive etigilimab (every 2 weeks) in combination with nivolumab (240 mg every 2 weeks).
Condition/Disease: Advanced Solid Tumors
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(Read more) NGM Bio Protocol 831-IO-101 - A Phase 1/1b dose escalation /expansion study of NGM831 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors
Summary: Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma - Metastatic Melanoma, Pancreatic Cancer, Phase I Clinical Trials, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma
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(Read more) Seattle Genetics Protocol SGNSTNV-001 - A study of SGN-STNV in advanced solid tumors
Summary: This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Phase I Clinical Trials, Endometrial Cancer, Lung Cancer - Non-Small Cell
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(Read more) Shionogi Protocol 2023P2411 - A phase 1b/2, multicenter, open-label study of S-531011 as monotherapy and in combination with an immune checkpoint inhibitor in participants with locally advanced or metastatic solid tumors
Summary: The primary objective of Part A is to evaluate the safety and tolerability of S-531011 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of S-531011.
The primary objective of Parts B and C is to evaluate the antitumor activity of S-531011 at the RP2D.
Condition/Disease: Advanced Solid Tumors
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(Read more) Takeda Protocol TAK-573-1001 - An Open-Label, Dose-Escalation Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-573 as a Single Agent and in Combination with Pembrolizumab in Adult Patients with Metastatic Solid Tumors
Summary: This study has 2 phases.
The main aims of Phase 1b are:
-to check for side effects from modakafusp alfa in adults with locally advanced or metastatic solid tumors.
-to learn how much modakafusp alfa adults can receive without getting any major side effects from it.
The main aims of Phase 2 are:
-to check for side effects from modakafusp alfa when given together with pembrolizumab in adults with metastatic cutaneous melanoma which cannot be completely removed by surgery.
-to learn how these medicines improve their symptoms.
Participants will receive modakafusp alfa for up to 1 year (Phase 1b) or modakafusp alfa given together with pembrolizumab for up to 2 years (Phase 2). Those whose symptoms improve might continue treatment for longer.
In both phases of the study, participants will revisit the study clinic within 30 days after their last dose or before they start other cancer treatment, whichever happens first.
Condition/Disease: Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials
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(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
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(Read more) TyrNovo Protocol TYR-219-01 - A Phase 1/2 Study with Open-Label, Dose Escalation Phase Followed by Single-Arm Expansion at the Maximum Tolerated Dose to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of NT219 Injection alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced solid tumors and Head and Neck cancer
Summary: This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials, Head and Neck Cancer
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Basal Cell Cancer Skin

(Read more) Immunocore Protocol IMC-F106C-101 - A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers Melanoma
Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Condition/Disease: Breast Cancer, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Sarcoma, Bladder Cancer, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Lung Cancer - Non-Small Cell
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(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Bladder Cancer

(Read more) Immunocore Protocol IMC-F106C-101 - A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers Melanoma
Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Condition/Disease: Breast Cancer, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Sarcoma, Bladder Cancer, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
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Breast Cancer

(Read more) Agenus Protocol C-800-01 - A phase 1 study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer
Summary: This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.
Condition/Disease: Breast Cancer, Ovarian Cancer, Sarcoma, Endometrial Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma
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(Read more) BMS Protocol IM043-004 - A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination with Chemotherapy or Nivolumab in Advanced Solid Tumors
Condition/Disease: Breast Cancer, Sarcoma, Colon Cancer, Pancreatic Cancer, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma

(Read more) Immunocore Protocol IMC-F106C-101 - A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers Melanoma
Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Condition/Disease: Breast Cancer, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Sarcoma, Bladder Cancer, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) XL092-001 - A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Condition/Disease: Breast Cancer, Colon Cancer, Phase I Clinical Trials, Renal Cell Carcinoma, Prostate Cancer

Cervical Cancer

(Read more) Exelixis Protocol XB002-101 - A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Summary: This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with nivolumab or bevacizumab to subjects with advanced solid tumors.
Condition/Disease: Ovarian Cancer, Pancreatic Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

Cholangiocarcinoma

(Read more) Incyte Protocol INCA 0186-101 - A phase 1, open-label, multicenter study of INCA00186 as monotherapy or in combination with immunotherapy in participants with advanced solid tumors
Summary: This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Pancreatic Cancer, Phase I Clinical Trials
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Colon Cancer

(Read more) BMS Protocol IM043-004 - A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination with Chemotherapy or Nivolumab in Advanced Solid Tumors
Condition/Disease: Breast Cancer, Sarcoma, Colon Cancer, Pancreatic Cancer, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

(Read more) XL092-001 - A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Condition/Disease: Breast Cancer, Colon Cancer, Phase I Clinical Trials, Renal Cell Carcinoma, Prostate Cancer

Colorectal Cancer

(Read more) DayOne Protocol DAY101-102 - A phase 1b/2, open label study of DAY101 monotherapy or combination with other therapies for patients with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations
Summary: This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent or progressive solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) Incyte Protocol INCA 0186-101 - A phase 1, open-label, multicenter study of INCA00186 as monotherapy or in combination with immunotherapy in participants with advanced solid tumors
Summary: This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Pancreatic Cancer, Phase I Clinical Trials
Read more on NCI

(Read more) KZR-261-101 - A Phase1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects with Advanced Solid Malignancies
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Mesothelioma, Prostate Cancer

(Read more) Novartis daNIS-3 Protocol CNIS793E12201 - An open-label, multi-center, phase II platform study evaluating the efficacy and safety of NIS793 and other new investigational drug combinations with standard of care (SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer (mCRC)
Summary: The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793 and other novel investigational combinations with standard of care (SOC) anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of mCRC. This study aims to explore whether different mechanisms of action may reverse resistance and improve responsiveness to the currently considered SOC anti-cancer therapy in the second line metastatic colorectal cancer (mCRC) setting.
Condition/Disease: Colorectal Cancer
Read more on NCI

Endometrial Cancer

(Read more) Agenus Protocol C-800-01 - A phase 1 study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer
Summary: This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.
Condition/Disease: Breast Cancer, Ovarian Cancer, Sarcoma, Endometrial Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma
Read more on NCI

(Read more) GSK Protocol 212214 - A Phase 1 First-Time-in-Human, Open-Label Study of GSK6097608 Administered as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Tumors
Summary: This first-time-in-human (FTIH) study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of escalating doses of GSK6097608 given as monotherapy and in combination with dostarlimab in participants with advanced solid tumors. In addition, dostarlimab will be given as monotherapy and in combination with GSK6097608 and with GSK4428859A (EOS884448) in Japanese and Chinese participants. Drug name mentioned as GSK4428859A and EOS884448 are interchangeable for the same compound. In the rest of the document, the drug will be referred to as GSK4428859A (EOS884448).
Condition/Disease: Endometrial Cancer
Read more on NCI

(Read more) Immunocore Protocol IMC-F106C-101 - A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers Melanoma
Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Condition/Disease: Breast Cancer, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Sarcoma, Bladder Cancer, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) Seattle Genetics Protocol SGNSTNV-001 - A study of SGN-STNV in advanced solid tumors
Summary: This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Phase I Clinical Trials, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

Esophageal Cancer

(Read more) Incyte Protocol INCA 0186-101 - A phase 1, open-label, multicenter study of INCA00186 as monotherapy or in combination with immunotherapy in participants with advanced solid tumors
Summary: This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Pancreatic Cancer, Phase I Clinical Trials
Read more on NCI

(Read more) Leap Protocol DEK-DKK1-P205 - A Phase 2a, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (DisTinGuish)
Summary: A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma.
Condition/Disease: Gastric Cancer, Esophageal Cancer
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

Gastric Cancer

(Read more) Astellas Protocol 8951-CL-0103 - A Phase 2 Study of IMAB362 as Monotherapy or in Combination with mFOLFOX6 in Subjects with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma whose Tumors have High or Intermediate Claudin (CLDN) 18.2 Expression
Summary: The purpose of this study is to determine the Objective Response Rate (ORR) of zolbetuzimab as a single agent as assessed by an independent central reader. This study will also assess the ORR and Progression Free Survival (PFS) of zolbetuximab in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab, assess the safety and tolerability, assess the effects on CLDN18.2 expression and assess the immunogenicity and immunomodulatory effects of zolbetuximab as a single agent and in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab. This study will also evaluate the pharmacokinetics (PK) of zolbetuximab, oxaliplatin, fluorouracil (5-FU), and pembrolizumab, evaluate health-Related Quality of Life (HRQoL), evaluate the Disease Control Rate (DCR), Duration of Response (DOR), PFS of zolbetuximab as a single agent, in combination with mFOLFOX6 (with or without Nivolumab) and in combination with pembrolizumab based on both investigator and independent central reader assessment, assess Overall Survival (OS) of zolbetuximab as a single agent and in combination with pembrolizumab.
Condition/Disease: Gastric Cancer
Read more on NCI

(Read more) Incyte Protocol INCA 0186-101 - A phase 1, open-label, multicenter study of INCA00186 as monotherapy or in combination with immunotherapy in participants with advanced solid tumors
Summary: This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Pancreatic Cancer, Phase I Clinical Trials
Read more on NCI

(Read more) Leap Protocol DEK-DKK1-P205 - A Phase 2a, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (DisTinGuish)
Summary: A Phase 2, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma.
Condition/Disease: Gastric Cancer, Esophageal Cancer
Read more on NCI

(Read more) NGM Bio Protocol 831-IO-101 - A Phase 1/1b dose escalation /expansion study of NGM831 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors
Summary: Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma - Metastatic Melanoma, Pancreatic Cancer, Phase I Clinical Trials, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma
Read more on NCI

(Read more) Seattle Genetics Protocol SGNSTNV-001 - A study of SGN-STNV in advanced solid tumors
Summary: This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Phase I Clinical Trials, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

Head and Neck Cancer

(Read more) BMS Protocol IM043-004 - A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination with Chemotherapy or Nivolumab in Advanced Solid Tumors
Condition/Disease: Breast Cancer, Sarcoma, Colon Cancer, Pancreatic Cancer, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma

(Read more) IIT2019-20-Zumsteg-HPVOPC - Phase II Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer
Condition/Disease: Head and Neck Cancer

(Read more) Immunocore Protocol IMC-F106C-101 - A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers Melanoma
Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Condition/Disease: Breast Cancer, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Sarcoma, Bladder Cancer, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) NGM Bio Protocol 831-IO-101 - A Phase 1/1b dose escalation /expansion study of NGM831 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors
Summary: Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma - Metastatic Melanoma, Pancreatic Cancer, Phase I Clinical Trials, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma
Read more on NCI

(Read more) Pfizer Protocol C4401001 - A phase 1 dose escalation and expansion study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07257876 in patients with advanced or metastatic tumors
Summary: This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic and potential clinical benefit of PF-07257876, a CD47-PD-L1 bispecific antibody, in participants with selected advanced or metastatic tumors for whom no standard therapy is available. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07257876, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
Condition/Disease: Head and Neck Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) Seattle Genetics SGN35-33 - A phase 2 study of brentuximab vedotin in combination with pembrolizumab in subjects with metastatic solid malignancies after progression on prior PD-1 inhibitor treatment
Summary: This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic).
The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer.
This is a multi-cohort study.
Condition/Disease: Melanoma - Metastatic Melanoma, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Melanoma – Adjuvant Therapy
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
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(Read more) TyrNovo Protocol TYR-219-01 - A Phase 1/2 Study with Open-Label, Dose Escalation Phase Followed by Single-Arm Expansion at the Maximum Tolerated Dose to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of NT219 Injection alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced solid tumors and Head and Neck cancer
Summary: This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials, Head and Neck Cancer
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Hepatocellular Carcinoma

(Read more) Agenus Protocol C-800-01 - A phase 1 study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer
Summary: This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.
Condition/Disease: Breast Cancer, Ovarian Cancer, Sarcoma, Endometrial Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

Lung Cancer - Non-Small Cell

(Read more) Agenus Protocol C-800-01 - A phase 1 study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer
Summary: This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.
Condition/Disease: Breast Cancer, Ovarian Cancer, Sarcoma, Endometrial Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma
Read more on NCI

(Read more) BMS Protocol IM043-004 - A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination with Chemotherapy or Nivolumab in Advanced Solid Tumors
Condition/Disease: Breast Cancer, Sarcoma, Colon Cancer, Pancreatic Cancer, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma

(Read more) DayOne Protocol DAY101-102 - A phase 1b/2, open label study of DAY101 monotherapy or combination with other therapies for patients with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations
Summary: This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent or progressive solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Lung Cancer - Non-Small Cell
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(Read more) Exelixis Protocol XB002-101 - A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Summary: This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with nivolumab or bevacizumab to subjects with advanced solid tumors.
Condition/Disease: Ovarian Cancer, Pancreatic Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell
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(Read more) IIT2021-12-Reckamp-Osi105 - Phase 1 Study of Osimertinib with Carotuximab in Advanced, EGFR-mutated Non-small Cell Lung Cancer
Condition/Disease: Lung Cancer - Non-Small Cell
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(Read more) Immunocore Protocol IMC-F106C-101 - A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers Melanoma
Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Condition/Disease: Breast Cancer, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Sarcoma, Bladder Cancer, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) NGM Bio Protocol 831-IO-101 - A Phase 1/1b dose escalation /expansion study of NGM831 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors
Summary: Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma - Metastatic Melanoma, Pancreatic Cancer, Phase I Clinical Trials, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma
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(Read more) Pfizer Protocol C4401001 - A phase 1 dose escalation and expansion study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07257876 in patients with advanced or metastatic tumors
Summary: This is a first-in-human, Phase 1, open label, multicenter, multiple dose, dose escalation and dose expansion study intended to evaluate the safety, pharmacokinetic, pharmacodynamic and potential clinical benefit of PF-07257876, a CD47-PD-L1 bispecific antibody, in participants with selected advanced or metastatic tumors for whom no standard therapy is available. The study contains 2 parts, single agent Dose Escalation (Part 1) to determine the recommended dose of PF-07257876, followed by Dose Expansion (Part 2) in selected tumor types at the recommended dose.
Condition/Disease: Head and Neck Cancer, Lung Cancer - Non-Small Cell
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(Read more) Seagen Protocol SGNS40-002 - An open-label, phase 2 basket study of SEA-CD40 combination therapies in advanced malignancies.
Summary: This trial is being done to see if an experimental drug (SEA-CD40) works when it's given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug.
There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can't be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed.
Condition/Disease: Melanoma, Lung Cancer - Non-Small Cell
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(Read more) Seattle Genetics Protocol SGN228-001 - A phase 1 study of SGN-CD228A in select advanced solid tumors
Summary: This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.
Condition/Disease: Pancreatic Cancer, Lung Cancer - Non-Small Cell
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(Read more) Seattle Genetics Protocol SGNSTNV-001 - A study of SGN-STNV in advanced solid tumors
Summary: This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Phase I Clinical Trials, Endometrial Cancer, Lung Cancer - Non-Small Cell
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(Read more) Seattle Genetics SGN35-33 - A phase 2 study of brentuximab vedotin in combination with pembrolizumab in subjects with metastatic solid malignancies after progression on prior PD-1 inhibitor treatment
Summary: This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic).
The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer.
This is a multi-cohort study.
Condition/Disease: Melanoma - Metastatic Melanoma, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Melanoma – Adjuvant Therapy
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Tmunity Protocol CART-TnMUC1-01 - A phase 1, open-label, multi-center first in human study of TnMUC1-Targeted genetically-modified chimeric antigen receptor T cells in patients with advanced TnMUC1-positive solid tumors and multiple myeloma
Summary: Multi-center, open-label, first in human Phase 1 study of the safety, tolerability, feasibility, and preliminary efficacy of the administration of genetically modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells).
Condition/Disease: Ovarian Cancer, Lung Cancer - Non-Small Cell
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(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

Lung Cancer - Small Cell

(Read more) Immunocore Protocol IMC-F106C-101 - A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers Melanoma
Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Condition/Disease: Breast Cancer, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Sarcoma, Bladder Cancer, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

Lymphoma

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Melanoma

(Read more) BMS Protocol CA224-098 - Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versusNivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma (RELATIVITY 098)
Summary: The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.
Condition/Disease: Melanoma
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(Read more) Instil Bio ITIL-168-101 / ITLUTM01-UTM001 - A Phase 2, Open-label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects with Advanced Melanoma
Summary: DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).
Condition/Disease: Melanoma
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(Read more) Merck Protocol MK-3475-U02 - This trial is a multicenter phase 1/2 open-label rolling arm platform design of investigational agents with or without pembrolizumab or pembrolizumab alone in participants with Melanoma
Summary: Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.
The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.
Condition/Disease: Melanoma
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(Read more) Novartis Protocol CPDR001J2201 - A randomized, open-label, phase II open platform study evaluating the efficacy and safety of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma
Summary: The primary purpose of this study is to evaluate the efficacy of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma.
Condition/Disease: Melanoma
Intervention: Drug: Spartalizumab
Drug: LAG525
Drug: Capmatinib
Drug: Canakinumab
Drug: Ribociclib

(Read more) NYU S19-00008/BMS CA209-76Y - A Phase II Study of the Interleukin-6 Receptor Inhibitor Tocilizumab in Combination with Ipilimumab and Nivolumab in Patients with Unresectable Stage III or Stage IV Melanoma
Summary: This is a Phase II, open-label, single arm study. The study will consist of an assessment of the safety and tolerability of tocilizumab administered concurrently at 4 mg/kg every 6 weeks for 5 doses in combination with ipilimumab and nivolumab for four induction doses to week 12, then maintenance nivolumab alone up to one year to patients with advanced melanoma. Treatment will be divided into induction and maintenance phases. It is anticipated that this clinical study will inform the use of this 3-drug combination for further phase II and/or phase III clinical testing. The trial will include an assessment of the pharmacodynamic activity of tocilizumab administered in combination with ipilimumab and nivolumab.
Condition/Disease: Melanoma
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(Read more) Parker Institute Protocol PICI0014 - A Multicenter Phase 1b Randomized, Placebo-controlled, Blinded Study to Evaluate the Safety, Tolerability and Efficacy of Microbiome Study Intervention Administration in Combination with Anti-PD-1 Therapy in Adult Patients with Unresectable or Metastatic Melanoma
Summary: This study is designed to evaluate the safety and tolerability of treatment with oral microbiome study intervention (SER-401) or matching placebo in combination with anti-programmed cell death 1 (anti-PD-1) therapy (nivolumab) in participants with unresectable or metastatic melanoma. The study also intends to assess clinical outcomes, the impact of microbiome study intervention administration on the microbiome profile, and its association with clinical and immunological outcomes.
Condition/Disease: Melanoma
Intervention: Drug: Placebo for antibiotic
Drug: Vancomycin pretreatment
Drug: Nivolumab
Drug: Matching Placebo for SER-401
Drug: SER-401
Phase 1: This is a Phase 1b, multicenter, randomized, placebo-controlled, blinded study in adult participants with anti-PD-1 therapy naïve, unresectable or metastatic melanoma to evaluate the safety and tolerability of SER-401, or matching placebo in combination with anti-PD-1 therapy (nivolumab). Prior to initiating microbiome study intervention and nivolumab, participants will undergo an antibiotic or antibiotic placebo treatment lead-in to prime the gut microbiome for engraftment of the oral microbiome study intervention. Study intervention groups will be assessed for safety, changes in the microbiome, changes in the percentage of tumoral CD8 T cells, and antitumor activity. Participants must have measurable disease that can be biopsied and consent to baseline and on-treatment biopsies, as well as stool and blood biomarker collection throughout the study.

(Read more) Seagen Protocol SGNS40-002 - An open-label, phase 2 basket study of SEA-CD40 combination therapies in advanced malignancies.
Summary: This trial is being done to see if an experimental drug (SEA-CD40) works when it's given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug.
There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can't be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed.
Condition/Disease: Melanoma, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Melanoma - Metastatic Melanoma

(Read more) Alkermes Artistry-6 Protocol ALKS 4230-006 - A Phase 2 Study of ALKS 4230 Administered Subcutaneously as Monotherapy in patients with advanced melanoma who have previously received anti-PDL1 therapy
Summary: This study observes the antitumor activity, safety, tolerability, PK, and pharmacodynamics in patients with inoperable and/or metastatic melanoma following prior anti-PD-[L]-1 therapy
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) BMS Protocol CA224-127 - A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed dose Combination versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants with Previously Untreated Metastatic or Unresectable Melanoma
Condition/Disease: Melanoma - Metastatic Melanoma

(Read more) DayOne Protocol DAY101-102 - A phase 1b/2, open label study of DAY101 monotherapy or combination with other therapies for patients with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations
Summary: This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent or progressive solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Lung Cancer - Non-Small Cell
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(Read more) EA6192 - A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients with Advanced Melanoma (PET-Stop)
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) ENB Therapeutics Protocol ENB-003 - A phase 1/2A trial of ENB 003 in combination with pembrolizumab in subjects with advanced solid tumors
Summary: First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.
Condition/Disease: Ovarian Cancer, Melanoma - Metastatic Melanoma, Sarcoma, Pancreatic Cancer
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(Read more) Immunocore Protocol IMC-F106C-101 - A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers Melanoma
Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Condition/Disease: Breast Cancer, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Sarcoma, Bladder Cancer, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) Immunocore Protocol IMCgp100-201 - A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in Combination with Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab Compared to IMCgp100 Alone in Patients with Advanced Melanoma
Summary: This study is a Phase Ib/II, multi-center, open-label study of tebentafusp (IMCgp100) as a single agent and in combination with durvalumab (MEDI4736) and/or tremelimumab in metastatic cutaneous melanoma. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and to evaluate the anti-tumor activity of tebentafusp (IMCgp100) in combination with durvalumab (MEDI4736, programmed death-ligand 1 [PD-L1] inhibitor), tremelimumab (CLTA-4 inhibitor), and the combination of durvalumab with tremelimumab compared to single-agent tebentafusp (IMCgp100) alone. The study will enroll patients who have metastatic melanoma that is refractory to treatment with an anti-PD-1 inhibitor in the metastatic setting. This study will also evaluate the safety, tolerability, and anti-tumor activity of tebentafusp (IMCgp100) monotherapy in patients with advanced non-uveal melanoma who progressed on prior PD-1 inhibitors approved for the treatment of advanced melanoma; patients with BRAF mutations must be refractory to approved BRAF-based therapy.
Recent biologic evidence indicates that optimal responses to programmed cell death-1 (PD-1) directed therapy require the presence of CD8+ T cells in the tumor microenvironment and thus therapies such as tebentafusp (IMCgp100) that recruit these effector cells to the tumor may overcome pre-existing resistance to checkpoint blockade. This emerging biology of checkpoint inhibitor resistance suggests the combination of tebentafusp (IMCgp100) with checkpoint inhibition may have enhanced activity in patients with pre-existing resistance.
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) Incyte Protocol INCAGN 2385-201 - A phase 1-2 study of combination therapy with INCMGA00012(Anti-PD-1), INCAGN02385(Anti-LAG-3), and INCAGN02390(Anti-TIM-3) in participants with select advanced malignancies
Summary: The study will determine Recommended Phase 2 Dose for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012.
Condition/Disease: Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials
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(Read more) Iovance Protocol IOV-GM1-201 - A Phase 1/2, open-label study of PD-1 knockout tumor-infiltrating lymphocytes (IOV-4001) in participants with unresectable or metastatic melanoma or Stage III or IV non-small-cell lung cancer
Summary: This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).
Condition/Disease: Melanoma - Metastatic Melanoma
Read more on NCI

(Read more) KZR-261-101 - A Phase1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects with Advanced Solid Malignancies
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Mesothelioma, Prostate Cancer

(Read more) Lokon Protocol LOKON003 - A Phase I/II Trial Investigating LOAd703 in Combination with Atezolizumab in Malignant Melanoma
Summary: This study aims to evaluate safety and effect of combining an oncolytic adenovirus (delolimogene mupadenorepvec; LOAd703) with atezolizumab in patients with melanoma. LOAd703 will be administered intratumorally for up to 12 injections while atezolizumab will be administered intravenously for the duration of the active study visits (up to 57 weeks). The patients are then monitored for survival for maximum study participation of 48 months. The treatments will be given every 3 weeks. The patients will then be monitored for toxicity, PK, ADA, immune responses, virus shedding, tumor response by RECIST 1.1 and survival.
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) Merck Protocol MK-3475-U02-01 - A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma: Master (KEYNOTE-U02)
Condition/Disease: Melanoma - Metastatic Melanoma, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases
Read more on NCI

(Read more) NGM Bio Protocol 831-IO-101 - A Phase 1/1b dose escalation /expansion study of NGM831 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors
Summary: Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma - Metastatic Melanoma, Pancreatic Cancer, Phase I Clinical Trials, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma
Read more on NCI

(Read more) NYU EIITS22-00325 - A Phase II Study of the Interleukin-6 Receptor Blocking Antibody Sarilumab in Combination with Ipilimumab, Nivolumab and Relatlimab in Patients with Unresectable Stage III or Stage IV Melanoma
Summary: The study will evaluate how safe the study drug is, how well you tolerate it, and how it works in the body and the disease's response to the drug. The study drug being tested is sarilumab, when given with the combination of ipilimumab, nivolumab, and relatlimab in patients with stage III or stage IV melanoma that cannot be removed by surgery. Previous studies have provided a strong rationale for combining sarilumab, with ipilimumab, nivolumab and relatlimab in metastatic melanoma to reduce side effects and potentially work better for this type of cancer. Sarilumab is an FDA-approved inhibitor of the receptor for the cytokine IL-6, currently approved for the treatment of rheumatoid arthritis, but it is not FDA-approved to treat melanoma. This means that the use of Sarilumab to treat melanoma is considered investigational. The other drugs which will be administered in this study, ipilimumab and nivolumab, are also monoclonal antibodies, but they target different proteins. Ipilimumab and nivolumab are both approved by the FDA to treat advanced stage III and IV melanomas. The nivolumab + relatlimab FDC (fixed dose combination) being used in this study is considered investigational, meaning it is not approved by the FDA.
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) Regeneron Protocol R3767-ONC-2011 - A phase 3 trial of FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA
Summary: The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS)
The secondary objectives of the study are:
-To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS)
-To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab
-To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component
-To assess immunogenicity of fianlimab and cemiplimab
-To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults
-To characterize safety and tolerability of treatment in patients 12 to <18 years of age
-To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age
-To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab
-To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years
Condition/Disease: Melanoma - Metastatic Melanoma
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(Read more) Seattle Genetics SGN35-33 - A phase 2 study of brentuximab vedotin in combination with pembrolizumab in subjects with metastatic solid malignancies after progression on prior PD-1 inhibitor treatment
Summary: This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic).
The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer.
This is a multi-cohort study.
Condition/Disease: Melanoma - Metastatic Melanoma, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Melanoma – Adjuvant Therapy
Read more on NCI

(Read more) Substudy 02A - Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)
Condition/Disease: Melanoma - Metastatic Melanoma
Read more on NCI

(Read more) Substudy 02B - Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)
Condition/Disease: Melanoma - Metastatic Melanoma
Read more on NCI

(Read more) Takeda Protocol TAK-573-1001 - An Open-Label, Dose-Escalation Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-573 as a Single Agent and in Combination with Pembrolizumab in Adult Patients with Metastatic Solid Tumors
Summary: This study has 2 phases.
The main aims of Phase 1b are:
-to check for side effects from modakafusp alfa in adults with locally advanced or metastatic solid tumors.
-to learn how much modakafusp alfa adults can receive without getting any major side effects from it.
The main aims of Phase 2 are:
-to check for side effects from modakafusp alfa when given together with pembrolizumab in adults with metastatic cutaneous melanoma which cannot be completely removed by surgery.
-to learn how these medicines improve their symptoms.
Participants will receive modakafusp alfa for up to 1 year (Phase 1b) or modakafusp alfa given together with pembrolizumab for up to 2 years (Phase 2). Those whose symptoms improve might continue treatment for longer.
In both phases of the study, participants will revisit the study clinic within 30 days after their last dose or before they start other cancer treatment, whichever happens first.
Condition/Disease: Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials
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(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

Melanoma - Ocular Melanoma

(Read more) Foghorn Protocol FHD-286-C-001 - A phase 1, multicenter, open-label, dose escalation and expansion study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered FHD-286 in subjects with metastatic uveal melanoma
Summary: This Phase 1, multicenter, open-label, dose escalation and expansion study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 oral monotherapy in subjects with metastatic Uveal Melanoma (UM).
Condition/Disease: Melanoma - Ocular Melanoma
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(Read more) Honor Health Protocol TTFIELDS-UM - First in Human Early Feasibility Study of Tumor-Treating Fields in Combination with Nivolumab and Ipilimumab in Metastatic Uveal Melanoma
Summary: Tumor Treating Fields targeted to liver metastases may improve outcomes for patients with metastatic uveal melanoma treated with immune checkpoint inhibitors.
Condition/Disease: Melanoma - Ocular Melanoma
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(Read more) Immunocore Protocol IMC-F106C-101 - A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers Melanoma
Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Condition/Disease: Breast Cancer, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Sarcoma, Bladder Cancer, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) KZR-261-101 - A Phase1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects with Advanced Solid Malignancies
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Mesothelioma, Prostate Cancer

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Melanoma – Adjuvant Therapy

(Read more) Merck 7684A-010 - A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab with Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants with High-risk Stage II-IV Melanoma (KEYVIBE-010)
Condition/Disease: Melanoma – Adjuvant Therapy
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(Read more) Moderna Protocol mRNA-4157-P201 - A phase 2 randomized study of adjuvant immunotherapy with the personalized cancer vaccine mRNA-4157 and pembrolizumab versus pembrolizumab alone after complete resection of high-risk melanoma
Summary: The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in patients with complete resection of cutaneous melanoma and a high risk of recurrence.
Condition/Disease: Melanoma – Adjuvant Therapy

(Read more) NKI CA209-6FR/M21NDN (NADINA) - Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab in macroscopic stage III melanoma – NADINA
Condition/Disease: Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy
Read more on NCI

(Read more) Seattle Genetics SGN35-33 - A phase 2 study of brentuximab vedotin in combination with pembrolizumab in subjects with metastatic solid malignancies after progression on prior PD-1 inhibitor treatment
Summary: This trial will find out whether brentuximab vedotin and pembrolizumab work together to treat different types of cancer. There will be several different types of cancer studied in the trial. The cancer must have spread to other parts of the body (metastatic).
The study will also find out what side effects occur. A side effect is anything the treatment does besides treat cancer.
This is a multi-cohort study.
Condition/Disease: Melanoma - Metastatic Melanoma, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Melanoma – Adjuvant Therapy
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Melanoma – Brain Metastases

(Read more) Merck Protocol MK-3475-U02-01 - A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma: Master (KEYNOTE-U02)
Condition/Disease: Melanoma - Metastatic Melanoma, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases
Read more on NCI

(Read more) Substudy 02D - Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Melanoma Brain Metastasis (MK-3475-02D/KEYMAKER-U02)
Condition/Disease: Melanoma – Brain Metastases
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Melanoma – NeoAdjuvant Therapy

(Read more) Merck Protocol MK-3475-U02-01 - A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Melanoma: Master (KEYNOTE-U02)
Condition/Disease: Melanoma - Metastatic Melanoma, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases
Read more on NCI

(Read more) NKI CA209-6FR/M21NDN (NADINA) - Multicenter phase 3 trial comparing NeoADjuvant Ipilimumab + Nivolumab versus standard Adjuvant nivolumab in macroscopic stage III melanoma – NADINA
Condition/Disease: Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy
Read more on NCI

(Read more) Substudy 02C - Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)
Condition/Disease: Melanoma – NeoAdjuvant Therapy
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Merkel Cell Carcinoma

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

Mesothelioma

(Read more) KZR-261-101 - A Phase1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects with Advanced Solid Malignancies
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Mesothelioma, Prostate Cancer

Neuroendocrine Cancer

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Ovarian Cancer

(Read more) Agenus Protocol C-800-01 - A phase 1 study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer
Summary: This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.
Condition/Disease: Breast Cancer, Ovarian Cancer, Sarcoma, Endometrial Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma
Read more on NCI

(Read more) ENB Therapeutics Protocol ENB-003 - A phase 1/2A trial of ENB 003 in combination with pembrolizumab in subjects with advanced solid tumors
Summary: First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.
Condition/Disease: Ovarian Cancer, Melanoma - Metastatic Melanoma, Sarcoma, Pancreatic Cancer
Read more on NCI

(Read more) Exelixis Protocol XB002-101 - A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Summary: This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with nivolumab or bevacizumab to subjects with advanced solid tumors.
Condition/Disease: Ovarian Cancer, Pancreatic Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) NGM Bio Protocol 831-IO-101 - A Phase 1/1b dose escalation /expansion study of NGM831 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors
Summary: Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma - Metastatic Melanoma, Pancreatic Cancer, Phase I Clinical Trials, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma
Read more on NCI

(Read more) Seattle Genetics Protocol SGNSTNV-001 - A study of SGN-STNV in advanced solid tumors
Summary: This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Phase I Clinical Trials, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Tmunity Protocol CART-TnMUC1-01 - A phase 1, open-label, multi-center first in human study of TnMUC1-Targeted genetically-modified chimeric antigen receptor T cells in patients with advanced TnMUC1-positive solid tumors and multiple myeloma
Summary: Multi-center, open-label, first in human Phase 1 study of the safety, tolerability, feasibility, and preliminary efficacy of the administration of genetically modified autologous T cells (CART-TnMUC1 cells) engineered to express a chimeric antigen receptor (CAR) capable of recognizing the tumor antigen, TnMUC1 and activating the T cell (CART- TnMUC1 cells).
Condition/Disease: Ovarian Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

Pancreatic Cancer

(Read more) Arcus Protocol AB680CSP00902 - A Phase 1 Study to Evaluate the Safety and Tolerability of AB680 Combination Therapy in Participants with Gastrointestinal Malignancies tumors
Summary: This is a Phase 1, open-label, dose-escalation, and dose-expansion, with a gated randomization portion, study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and clinical activity of AB680 in combination with Zimberelimab (AB122), nab-paclitaxel and gemcitabine in participants with advanced pancreatic cancer.
Condition/Disease: Pancreatic Cancer
Read more on NCI

(Read more) Biontech Protocol MV-0715-CP-001.01 - Phase 1 safety and tolerability study fo human monoclonal antibody 5B1(MVT-5873) with expansion in subjects with pancreatic cancer or other CA19-9 positive malignancies
Summary: Phase 1 Safety and Tolerability Study in Subjects with Pancreatic Cancer or Other CA19-9 Positive Malignancies.
Condition/Disease: Pancreatic Cancer
Read more on NCI

(Read more) BMS Protocol IM043-004 - A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination with Chemotherapy or Nivolumab in Advanced Solid Tumors
Condition/Disease: Breast Cancer, Sarcoma, Colon Cancer, Pancreatic Cancer, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma

(Read more) ENB Therapeutics Protocol ENB-003 - A phase 1/2A trial of ENB 003 in combination with pembrolizumab in subjects with advanced solid tumors
Summary: First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.
Condition/Disease: Ovarian Cancer, Melanoma - Metastatic Melanoma, Sarcoma, Pancreatic Cancer
Read more on NCI

(Read more) Exelixis Protocol XB002-101 - A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XB002 in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Summary: This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with nivolumab or bevacizumab to subjects with advanced solid tumors.
Condition/Disease: Ovarian Cancer, Pancreatic Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) Incyte Protocol INCA 0186-101 - A phase 1, open-label, multicenter study of INCA00186 as monotherapy or in combination with immunotherapy in participants with advanced solid tumors
Summary: This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Pancreatic Cancer, Phase I Clinical Trials
Read more on NCI

(Read more) NGM Bio Protocol 831-IO-101 - A Phase 1/1b dose escalation /expansion study of NGM831 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors
Summary: Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma - Metastatic Melanoma, Pancreatic Cancer, Phase I Clinical Trials, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma
Read more on NCI

(Read more) Seattle Genetics Protocol SGN228-001 - A phase 1 study of SGN-CD228A in select advanced solid tumors
Summary: This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.
Condition/Disease: Pancreatic Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Phase I Clinical Trials

(Read more) AstraZeneca Protocol D8151C00001 - A phase II study to evaluate the safety, pharmaco kinetics, and clinical activity of AZD0171 in combination with durvalumab and chemotherapy in participants with locally advanced or metastatic solid tumors
Summary: The proposed study is designed to examine the effects of AZD0171 and durvalumab in combination with standard-of-care chemotherapy in patients with pancreatic ductal adenocarcinoma (PDAC).
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
Read more on NCI

(Read more) Bioatla Protocol BA3071-001 - A phase ½ study of BA3071 in combination with NIVOLUMAB IN PATIENTS WITH ADVANCED SOLID TUMORS
Summary: The objective of this study is to assess safety and efficacy of BA3071 in solid tumors.
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
Read more on NCI

(Read more) BMS Protocol CA111-001 - A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants with Advanced Malignant Tumors
Summary: The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone and in combination with nivolumab in participants with advanced tumors.
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
Read more on NCI

(Read more) DayOne Protocol DAY101-102 - A phase 1b/2, open label study of DAY101 monotherapy or combination with other therapies for patients with recurrent, progressive, or refractory solid tumors harboring MAPK pathway aberrations
Summary: This is a Phase 1b/2, multi-center, open label umbrella study of patients ≥12 years of age with recurrent or progressive solid tumors with alterations in the key proteins of the RAS/RAF/MEK/ERK pathway, referred to as the MAPK pathway.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) DZ002 - A Pharmacokinetic and Pharmacodynamic Study of DZ-002 in Patients With Advanced Solid Malignancies or Lymphoma
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials
Read more on NCI

(Read more) Incyte Protocol INCA 0186-101 - A phase 1, open-label, multicenter study of INCA00186 as monotherapy or in combination with immunotherapy in participants with advanced solid tumors
Summary: This is an open-label, nonrandomized, multicenter, dose escalation, and dose expansion first-in human (FIH) Phase 1 study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCA00186 when given alone or in combination with INCB106385 and/or retifanlimab in participants with specific advanced solid tumors; squamous cell carcinoma of the head and neck (SCCHN) and specified gastrointestinal (GI) malignancies have been selected as indications of interest for this study. Participants with CD8 T-cell-positive tumors will be selected as these tumors are more likely to respond to immunotherapy.
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Pancreatic Cancer, Phase I Clinical Trials
Read more on NCI

(Read more) Incyte Protocol INCAGN 2385-201 - A phase 1-2 study of combination therapy with INCMGA00012(Anti-PD-1), INCAGN02385(Anti-LAG-3), and INCAGN02390(Anti-TIM-3) in participants with select advanced malignancies
Summary: The study will determine Recommended Phase 2 Dose for all study drugs, based on the safety and tolerability of the following combinations: INCAGN02385 + INCAGN02390 and INCAGN02385 + INCAGN02390 + INCMGA00012.
Condition/Disease: Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials
Read more on NCI

(Read more) KZR-261-101 - A Phase1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects with Advanced Solid Malignancies
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Mesothelioma, Prostate Cancer

(Read more) NGM Bio Protocol 831-IO-101 - A Phase 1/1b dose escalation /expansion study of NGM831 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors
Summary: Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma - Metastatic Melanoma, Pancreatic Cancer, Phase I Clinical Trials, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma
Read more on NCI

(Read more) Seattle Genetics Protocol SGNSTNV-001 - A study of SGN-STNV in advanced solid tumors
Summary: This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.
The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Phase I Clinical Trials, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) Takeda Protocol TAK-573-1001 - An Open-Label, Dose-Escalation Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-573 as a Single Agent and in Combination with Pembrolizumab in Adult Patients with Metastatic Solid Tumors
Summary: This study has 2 phases.
The main aims of Phase 1b are:
-to check for side effects from modakafusp alfa in adults with locally advanced or metastatic solid tumors.
-to learn how much modakafusp alfa adults can receive without getting any major side effects from it.
The main aims of Phase 2 are:
-to check for side effects from modakafusp alfa when given together with pembrolizumab in adults with metastatic cutaneous melanoma which cannot be completely removed by surgery.
-to learn how these medicines improve their symptoms.
Participants will receive modakafusp alfa for up to 1 year (Phase 1b) or modakafusp alfa given together with pembrolizumab for up to 2 years (Phase 2). Those whose symptoms improve might continue treatment for longer.
In both phases of the study, participants will revisit the study clinic within 30 days after their last dose or before they start other cancer treatment, whichever happens first.
Condition/Disease: Advanced Solid Tumors, Melanoma - Metastatic Melanoma, Phase I Clinical Trials
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

(Read more) TyrNovo Protocol TYR-219-01 - A Phase 1/2 Study with Open-Label, Dose Escalation Phase Followed by Single-Arm Expansion at the Maximum Tolerated Dose to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of NT219 Injection alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced solid tumors and Head and Neck cancer
Summary: This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.
Condition/Disease: Advanced Solid Tumors, Phase I Clinical Trials, Head and Neck Cancer
Read more on NCI

(Read more) XL092-001 - A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Condition/Disease: Breast Cancer, Colon Cancer, Phase I Clinical Trials, Renal Cell Carcinoma, Prostate Cancer

Prostate Cancer

(Read more) KZR-261-101 - A Phase1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects with Advanced Solid Malignancies
Condition/Disease: Colorectal Cancer, Advanced Solid Tumors, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Phase I Clinical Trials, Mesothelioma, Prostate Cancer

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) XL092-001 - A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Condition/Disease: Breast Cancer, Colon Cancer, Phase I Clinical Trials, Renal Cell Carcinoma, Prostate Cancer

Renal Cell Carcinoma

(Read more) BMS Protocol IM043-004 - A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination with Chemotherapy or Nivolumab in Advanced Solid Tumors
Condition/Disease: Breast Cancer, Sarcoma, Colon Cancer, Pancreatic Cancer, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma

(Read more) Exelixis Protocol XL092-001 - A dose -escalation and expansion study of the safety and pharmacokinetics of XL092 as single-agent and combination therapy in subject with inoperable locally advanced or metastatic solid tumors
Summary: This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.
Condition/Disease: Renal Cell Carcinoma
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(Read more) NGM Bio Protocol 831-IO-101 - A Phase 1/1b dose escalation /expansion study of NGM831 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors
Summary: Study of NGM831 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors.
Condition/Disease: Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma - Metastatic Melanoma, Pancreatic Cancer, Phase I Clinical Trials, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

(Read more) Treadwell Protocol TWT-101 - A First In-Human, Phase 1/2 Study of Cfi-402411, Hematopoietic Progenitor Kinase-1 (Hpk1) Inhibitor, As A Single Agent And In Combination With Pembrolizumab In Subjects With Advanced Solid Malignancies
Summary: The purpose of this study is to test the safety of an investigational drug called CFI-402411 alone and in combination with pembrolizumab and to study its effects in patients with advanced solid tumors who have progressed following previous therapies.
Condition/Disease: Advanced Solid Tumors, Gastric Cancer, Melanoma - Metastatic Melanoma, Merkel Cell Carcinoma, Esophageal Cancer, Colon Cancer, Bladder Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Cervical Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma
Read more on NCI

(Read more) XL092-001 - A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects with Inoperable Locally Advanced or Metastatic Solid Tumors
Condition/Disease: Breast Cancer, Colon Cancer, Phase I Clinical Trials, Renal Cell Carcinoma, Prostate Cancer

Sarcoma

(Read more) Agenus Protocol C-800-01 - A phase 1 study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer
Summary: This study is an open-label, Phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) profiles of a novel fragment crystallizable (Fc)-engineered immunoglobulin G1 anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA-4) human monoclonal antibody (botensilimab) monotherapy and in combination with an anti-programmed cell death protein-1 (PD-1) antibody (balstilimab), and to assess the maximum tolerated dose (MTD) in participants with advanced solid tumors. This study will also determine the recommended phase 2 dose (RP2D) of botensilimab monotherapy and in combination with balstilimab.
Condition/Disease: Breast Cancer, Ovarian Cancer, Sarcoma, Endometrial Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma
Read more on NCI

(Read more) BMS Protocol IM043-004 - A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination with Chemotherapy or Nivolumab in Advanced Solid Tumors
Condition/Disease: Breast Cancer, Sarcoma, Colon Cancer, Pancreatic Cancer, Head and Neck Cancer, Lung Cancer - Non-Small Cell, Renal Cell Carcinoma

(Read more) ENB Therapeutics Protocol ENB-003 - A phase 1/2A trial of ENB 003 in combination with pembrolizumab in subjects with advanced solid tumors
Summary: First-in Human study evaluating the safety, tolerability and efficacy of ENB003 in combination with Pembrolizumab in solid tumors. The study is separated into two parts. Part A is a 3+3 dose escalation to define the recommended RP2D; this part will include metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer patients subjects, but other solid tumors will be allowed. Once the RP2D is selected, the study will be expanded into metastatic melanoma, platinum resistant ovarian cancer, and pancreatic cancer subjects. A small number of sarcoma subjects will be included, as exploratory.
Condition/Disease: Ovarian Cancer, Melanoma - Metastatic Melanoma, Sarcoma, Pancreatic Cancer
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(Read more) Immunocore Protocol IMC-F106C-101 - A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers Melanoma
Summary: IMC-F106C is an immune-mobilizing monoclonal T cell receptor against cancer (ImmTAC ®) designed for the treatment of cancers positive for the tumor-associated antigen PRAME. This is a first-in-human trial designed to evaluate the safety and efficacy of IMC-F106C in adult patients who have the appropriate HLA-A2 tissue marker and whose cancer is positive for PRAME
Condition/Disease: Breast Cancer, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Sarcoma, Bladder Cancer, Lung Cancer - Small Cell, Head and Neck Cancer, Endometrial Cancer, Lung Cancer - Non-Small Cell
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Squamous Cell Cancer Skin

(Read more) Regeneron Protocol R6569-ONC-1933 - A phase 1 study of REGN6569, an anti-GITR mAb, with cemiplimab in patients with advanced solid tumor malignancies
Summary: For dose escalation cohorts, the primary objective is to evaluate the safety and tolerability of REGN6569 as monotherapy lead-in and in combination with cemiplimab.
For dose expansion cohorts, the co-primary objectives are:
-To assess the preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by objective response rate (ORR)
-To assess the preliminary pharmacodynamic activity of REGN6569 as lead-in monotherapy, as measured by intratumoral Glucocorticoid-Induced Tumor necrosis factor receptor-Related (GITR)+ Treg depletion
Secondary Objectives are:
For dose escalation cohorts:
-To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by ORR, disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS)
-To characterize the pharmacokinetics (PK) of REGN6569 alone and in combination with cemiplimab
-To assess the immunogenicity of REGN6569 and cemiplimab
For expansion cohorts:
-To characterize the safety profile in each expansion cohort
-To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by DCR, DOR, PFS, and OS
-To characterize the PK of REGN6569 alone and in combination with cemiplimab
-To assess the immunogenicity of REGN6569 and cemiplimab
Condition/Disease: Squamous Cell Cancer Skin
Read more on NCI

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib

Uterine Cancer

(Read more) TAPUR - The Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Summary: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPURStudy relevant biomarkers. For additional information, contact [email protected], or if a patient, your nearest participating TAPUR site (see participating centers). Results will be made available at the end of the study, however results on individual cohorts are posted at www.tapur.org/news as they become available while the study is ongoing.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Condition/Disease: Breast Cancer, Lymphoma, Advanced Solid Tumors, Ovarian Cancer, Gastric Cancer, Melanoma, Melanoma - Ocular Melanoma, Melanoma - Metastatic Melanoma, Basal Cell Cancer Skin, Merkel Cell Carcinoma, Squamous Cell Cancer Skin, Sarcoma, Esophageal Cancer, Cholangiocarcinoma, Colon Cancer, Bladder Cancer, Pancreatic Cancer, Phase I Clinical Trials, Lung Cancer - Small Cell, Neuroendocrine Cancer, Head and Neck Cancer, Cervical Cancer, Endometrial Cancer, Uterine Cancer, Lung Cancer - Non-Small Cell, Hepatocellular Carcinoma, Renal Cell Carcinoma, Melanoma – Adjuvant Therapy, Melanoma – NeoAdjuvant Therapy, Melanoma – Brain Metastases, Prostate Cancer
Intervention: Drug: Crizotinib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab and Pertuzumab
Drug: Vemurafenib and Cobimetinib
Drug: Regorafenib
Drug: Olaparib
Drug: Pembrolizumab
Drug: Nivolumab and Ipilimumab
Drug: Abemaciclib
Drug: Afatinib
Drug: Talazoparib