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Melanoma Clinical Trials

Last updated 01/09/2023. For more information on these trials, call AskMDAnderson toll-free at 1-877-380-0046.

Neoadjuvant

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).

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

Pateints with Previous Treatment

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 goal of this clinical research study is to learn about the possible effects of two different diets targeting the gut microbiome in patients with melanoma being treated with immunotherapy drugs pembrolizumab or nivolumab as part of their standard of care. Both diets will be whole foods diets that meet the American Cancer Society recommendations for cancer patients, but they will vary in fiber content.

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 II Study of Open Label Low Dose Ipilimumab in Combination with Pembrolizumab in Metastatic Melanoma Patients with Brain Metastases (2018-0875). (NCT03873818)
Principal Investigator: Isabella Glitza, M.D.
The goal of this clinical research study is to learn if ipilimumab in combination with pembrolizumab can help to control melanoma that has spread to the brain. The safety of this drug combination will also be studied.

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.

Phase II Study of BEvacizumab (Avastin) in Combination with ATezolizumab or Atezolizumab (Tencentrig) and Cobimetinib (Cotellic) in Patients with Untreated Melanoma Brain Metastases (TACo-BEAT-MBM) (2016-0866). (NCT03175432)
Principal Investigator: Hussein Tawbi, M.D., Ph.D.
The goal of this clinical research study is to learn if the combination of bevacizumab and atezolizumab, with or without cobimetinib can help control the disease in patients with cancer that has spread to the brain. The safety of these drugs will also be studied.

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.

An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies (2021-0579). (NCT04993677)
Principal Investigator: Sapna P. Patel, M.D.
The goal of this clinical research study is to learn if the combination of SEA-CD40 and other drugs can help to control advanced forms of cancer. The safety of these drug combinations 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 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.

Patients with Uveal Melanoma

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 (2021-0020). (NCT04879017)
Principal Investigator: Sapna P. Patel, M.D.
The goal of Part 1 of this clinical research study is to find the highest tolerable dose of FHD-286 that can be given to patients with uveal melanoma that is metastatic (has spread in the body). The goal of Part 2 of this study is to learn if the dose of FHD-286 found in Part 1 can help to control the disease. The safety and effects of FHD-286 will also be studied in both parts of the study. This is the first study of FHD-286 in humans.

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.

An Open-label, Phase 2 Basket Study of SEA-CD40Combination Therapies in Advanced Malignancies (2021-0579). (NCT04993677)
Principal Investigator: Sapna P. Patel, M.D.
The goal of this clinical research study is to learn if the combination of SEA-CD40 and other drugs can help to control advanced forms of cancer. The safety of these drug combinations will also be studied.

Naive

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.

Patients with Non-Melanoma Skin Cancers

A Phase 1b/2, Open-Label Study Evaluating the Safety and Efficacy of KRT-232 in Patients with p53 Wild-Type (p53WT) Merkel Cell Carcinoma (MCC) Who Have Failed Anti-PD-1 or Anti-PD-L1 Immunotherapy, or in Combination with Avelumab in MCC Patients Who Are Anti-PD-1 or Anti-PD-L1 Treatment Naïve (2019-0028). (NCT03787602)
Principal Investigator: Michael Wong, M.D.
The goal of this clinical research study is to learn if navtemadlin (also called KRT-232) when given with or without avelumab can help to control Merkel Cell Carcinoma (MCC). The safety of this drug will also be studied.