Melanoma Clinical Trials

Neoadjuvant

Immune Related Toxicity and Symptom Burden In Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors (2019-0390). (NCT04990726)
Principal Investigator: Noha Abdelwahab Hassan, M.D., Ph.D.
This study evaluates the immune related toxicity and symptom burden in chronic cancer survivors with melanoma who are receiving adjuvant immunotherapy with immune checkpoint inhibitors. Information collected in this study may help doctors to learn more about the side effects caused by immunotherapy, and to learn if there are any relationships between these side effects and immune and genetic biomarkers found in the blood that may be related to patient's reaction to immunotherapy.

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients with Melanoma (Morpheus-Melanoma) (2021-0776). (NCT05116202)
Principal Investigator: Rodabe Amaria, M.D.
The overall goal of this clinical research study is to look at the safety and effectiveness of different cancer immunotherapy (CIT) treatment combinations in patients with melanoma that either has stayed in one part of the body (Treatment Cohort 1) or has spread to other parts of the body (Treatment Cohort 2).

Adjuvant

Diet and Immune Effects Trial: DIET- A randomized double blinded dietary intervention study in patients with metastatic melanoma receiving immunotherapy (2020-0158). (NCT04645680)
Principal Investigator: Jennifer McQuade, M.D.
The purpose of this trial is to learn about the effects of dietary interventions on the structure and function of the gut microbiome in patients with melanoma being treated with standard of care immunotherapy (pembrolizumab or nivolumab).

Alliance A091903: A randomized phase II trial of adjuvant Nivolumab with or without Cabozantinib in patients with resected mucosal melanoma (2023-0350 ). (NCT05111574)
Principal Investigator: Sapna P. Patel, M.D.
This phase II trial tests whether nivolumab in combination with cabozantinib works in patients with mucosal melanoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving nivolumab in combination with cabozantinib could prevent cancer from returning.

Immune Related Toxicity and Symptom Burden In Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors (2019-0390). (NCT04990726)
Principal Investigator: Noha Abdelwahab Hassan, M.D., Ph.D.
This study evaluates the immune related toxicity and symptom burden in chronic cancer survivors with melanoma who are receiving adjuvant immunotherapy with immune checkpoint inhibitors. Information collected in this study may help doctors to learn more about the side effects caused by immunotherapy, and to learn if there are any relationships between these side effects and immune and genetic biomarkers found in the blood that may be related to patient's reaction to immunotherapy.

Patients with Previous Treatment

A Phase 1/2, First-in-human, Multi-Part, Open-Label, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a monotherapy and in combination with Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications (2020-0916). (NCT04423029)
Principal Investigator: Hussein Tawbi, M.D., Ph.D.
The goal of this clinical research study is to find the highest tolerable dose of DF6002 either alone or in combination with nivolumab that can be given to patients with melanoma. This is the first study of DF6002 in humans.

A Phase 1 study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Hepatocellular Carcinoma not Amenable to Resection or Transplant (2016-0483).  (NCT00986661)
Principal Investigator: Sapna P. Patel, M.D.
The goal of this clinical research study is to learn about the safety and tolerability of PV-10 when given to patients who have melanoma that has spread to the liver.

A Phase Ib, Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of IN10018 as Monotherapy and Combination Therapy in Subjects with Metastatic Melanoma (2019-1180). (NCT04109456)
Principal Investigator: Sapna Patel, M.D.
The goal of this clinical research study is to test the safety of IN10018, when given alone or in combination with cobimetinib to patients with melanoma that is metastatic (has spread). The effects of the drug and drug combination will also be studied.

A Phase 1, Open-Label, Dose-Escalation with Expansion Study of SX-682 in Subjects with Metastatic Melanoma Concurrently Treated with Pembrolizumab (2021-0705). (NCT03161431)
Principal Investigator: Sapna P. Patel, M.D.
The goal of this clinical research study is to find the highest tolerable dose of SX-682 that can be given alone (Part 1) or with pembrolizumab (Part 2) to patients who have melanoma that is metastatic (has spread). The goal of Part 3 of this study is to learn if the dose of SX-682 found in Part 2 when given in combination with pembrolizumab can help to control the disease.

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients with Melanoma (Morpheus-Melanoma) (2021-0776). (NCT05116202)
Principal Investigator: Rodabe Amaria, M.D.
The overall goal of this clinical research study is to look at the safety and effectiveness of different cancer immunotherapy (CIT) treatment combinations in patients with melanoma that either has stayed in one part of the body (Treatment Cohort 1) or has spread to other parts of the body (Treatment Cohort 2).

A Pilot Study of Lymphodepletion Plus Adoptive Cell Transfer With TGF-Beta Resistant (DNRII) Transduced T-Cells Followed By High Dose Interleukin-2 in Patients with Metastatic Melanoma (2012-0758). (NCT01955460)
Principal Investigator: Rodabe Amaria, M.D.
The goal of Cohort B is to learn about the safety and effects of T-cells injected with the gene TGFb-DNR alone when given in combination with chemotherapy (cyclophosphamide and fludarabine) and alesleukin to patients with metastatic melanoma. The safety and effects of the study drug(s) will also be studied.

Phase II Study of Binimetinib with Encorafenib in Patients with Metastatic Melanoma and CNS metastases (2021-0205). (NCT05026983)
Principal Investigator: Isabella C. Glitza, M.D.
The goal of this clinical research study is to learn if the combination of encorafenib and binimetinib can help to control melanoma brain metastasis (melanoma that has spread to the brain) or leptomeningeal disease (LMD, when the cancer has spread to the lining of the brain) that has a genetic mutation (change) called BRAFV600. The safety of these drugs will also be studied.

Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered with Membrane Bound IL15 Plus Acetazolamide in Adult Patients with Metastatic Melanoma (2022-0356).  (NCT05470283)
Principal Investigator: Rodabe Amaria, M.D.
The goal is to find the recommended dose of OX-115 in combination with acetazolamide that can be given to patients with metastatic melanoma previously treated with immune checkpoint inhibitors.

Phase II study of olaparib in combination with pembrolizumab in patients with advanced melanoma with homologous recombination (HR) pathway gene mutation (2021-1032). (NCT04633902)
Principal investigator: Sapna Patel, M.D.
The goal of the study is to determine how well olaparib in combination with pembrolizumb works in treating patients with advanced, metastatic melnoma with the homologous recombination (HR) pathway gene mutation/alteration. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and potentially augmnet an anti-tumor immune response to pembrolizumab.

A Phase IB/2 Study of OKI-179 Plus Binimetinib in Patients with Advanced Solid Tumors and Activating Mutations in the RAS Pathway (Phase 1B) in Patients with Advanced NRAS-Mutated Melanoma (Phase 2) (2022-0275). (NCT05340621)
Principal Investigator: Rodabe Amaria, M.D.
The goal of Part 1 of this study is to find the highest tolerable dose of OKI-179 and binimetinib that can be given to patients who have certain types of advanced cancer. The safety and possible effects of the study drugs will also be studied. The goal of Part 2 of this study is to learn if the dose of OKI-179 and binimetinib found in Part 1 can help to control the disease.

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors (2022-0259). (NCT03767348)
Principal Investigator: Michael Wong, M.D.
The goal of this clinical research study is to learn if RP1, either given alone as an injection into the tumor or combined with nivolumab immunotherapy, is effective in controlling certain types of solid tumors. The safety of these treatments will also be studied.

Phase II study of Nivolumab in combination with Relatlimab in patients with active Melanoma brain metastases (2021-1203). (NCT05704647)
Principle Investigator: Hussein Tawbi, M.D.
The goal of the study is to learn if giving nivolumab in combination with relatlimab can help to control melanoma that has spread to the brain (melanoma with brain metastases). The safety and side effects of the study drug combination will also be studied.

A Phase 2 Study of Intratumoral Injection of LTX-315 in combination with Pembrolizumab in Patients with Percutaneously Accessible Lesions with Advanced Melanoma Refractory to Pembrolizumab (2021-0044). (NCT04796194)
Principle Investigator: Adi Diab, M.D.
The goal of this clinical research study is to learn if the combination of LTX-315 with pembrolizumab can help to control advanced melanoma. The safety and effects of
the drug combination will also be studied.

Patients with Uveal Melanoma

A Phase 1/1b, Open-Label Study of the Pressure-Enabled Hepatic Artery Infusion of SD-101, a TLR9 Agonist, Alone or in Combination with Intravenous Checkpoint Blockade in Adults with Metastatic Uveal Melanoma (2021-0052). (NCT04935229)
Principal Investigator: Sapna Patel, M.D.
The goal of this clinical research study is to learn if the study drug, SD-101, when given alone or in combination with nivolumab and/or ipilimumab can help to boost your immune system in order to help your body better “fight” uveal melanoma metastases (melanoma spreading to other places in the body, like the liver).

A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Hepatocellular Carcinoma not Amenable to Resection or Transplant (2016-0483). (NCT00986661)
Principal Investigator: Sapna P. Patel, M.D.
The goal of this clinical research study is to learn about the safety and tolerability of PV-10 when given to patients who have melanoma that has spread to the liver.

Naïve 

A Phase II Study to Assess the Safety and Efficacy of Tocilizumab in combination with Ipilimumab and Nivolumab in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Urothelial Carcinoma (2020-1166). (NCT04940299)
Principal Investigator: Adi Diab, M.D.
The goal of this clinical research study is to study the effectiveness of a triplet combination therapy (nivolumab, tocilizumab, and ipilimumab) in treating advanced melanoma, non-small-cell lung cancer, or urothelial carcinoma. The safety of this treatment combination will also be studied.

Alliance A091903: A randomized phase II trial of adjuvant Nivolumab with or without Cabozantinib in patients with resected mucosal melanoma (2023-0350 ). (NCT05111574)
Principal Investigator: Sapna P. Patel, M.D.
This phase II trial tests whether nivolumab in combination with cabozantinib works in patients with mucosal melanoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving nivolumab in combination with cabozantinib could prevent cancer from returning.

Patients with Non-Melanoma Skin Cancers

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors (2022-0259). (NCT03767348)
Principal Investigator: Michael Wong, M.D.
The goal of this clinical research study is to learn if RP1, either given alone as an injection into the tumor or combined with nivolumab immunotherapy, is effective in controlling certain types of solid tumors. The safety of these treatments will also be studied.