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.

Adjuvant

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: Jennifer McQuade, 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, 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.

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 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 pembrolizumab works in treating patients with advanced, metastatic melanoma 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 augment an anti-tumor immune response to pembrolizumab.

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 1 first-in-human study to investigate the safety, efficacy, pharmacokinetics, and pharmacodynamic activity of CLN-617 alone and in combination with Pembrolizumab in patients with advanced solid tumors. (Cullinan-2023-0517). (NCT06035744)
Principal Investigator: Adi Diab, M.D.
CLN-617-001 is a Phase 1, open-label, dose escalation, dose optimization and dose expansion study of CLN-617 alone and in combination with Pembrolizumab in patients with advanced solid tumors.

A phase 1/2 study of KSQ-001EX, autologous tumor Infiltrating Lymphocytes engineered to inactivate the SOCS1 gene, in patients with select advanced solid tumors. (2023-0571). (NCT06237881)
Principal Investigator: Rodabe Amaria, M.D.
The goal of this clinical research study is to learn if KSQ-001EX is safe to give to participants with advanced forms of solid tumors.

Patients with Uveal Melanoma

IDE196 (Darovasertib) in combination with Crizotinib versus investigator's choice of treatment as first-line therapy in hla-a2 negative metastatic uveal melanoma (dar-um-2) (2023-0582). (NCT05987332)
Principal Investigator: Sapna Patel, M.D.
This is a Phase 2/3, multi-arm, multi-stage, open-label study of human leukocyte antigen (HLA)-A*02:01 negative participants with metastatic uveal melanoma (MUM) who will be randomized to receive either IDE196 + crizotinib or investigator's choice of treatment (pembrolizumab, ipilimumab + nivolumab, or dacarbazine).

Naïve 

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: Jennifer McQuade, 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.