Treatment Clinical Trials for Melanoma

Clinical trials are research studies that involve people. The clinical trials on this list are for melanoma treatment. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

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  • Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
    Location: 1199 locations

  • A Study to Compare the Administration of Pembrolizumab after Surgery Versus Administration both before and after Surgery for High-Risk Melanoma

    This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.
    Location: 739 locations

  • Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients with Stage III-IV BRAFV600 Melanoma

    This phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.
    Location: 723 locations

  • A Phase II / III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients with Advanced Melanoma

    This phase II / III trial studies the side effects of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
    Location: 531 locations

  • Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients with Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial

    This phase II trial investigates how well biomarkers on PET / CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET / CT imaging and tumor biopsy.
    Location: 298 locations

  • A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma with Brain Metastases

    This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.
    Location: 250 locations

  • Pembrolizumab in Treating Patients with Desmoplastic Melanoma That Can or Cannot Be Removed by Surgery

    This pilot phase II trial studies how well pembrolizumab works in treating patients with desmoplastic melanoma (DM) that can be removed by surgery (resectable) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
    Location: 209 locations

  • Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders with HRAS Gene Alterations, a Pediatric MATCH Treatment Trial

    This phase II pediatric MATCH trial studies how well tipifarnib works in treating patients with solid tumors that have recurred or spread to other places in the body (advanced), lymphoma, or histiocytic disorders, that have a genetic alteration in the gene HRAS. Tipifarnib may block the growth of cancer cells that have specific genetic changes in a gene called HRAS and may reduce tumor size.
    Location: 168 locations

  • Testing the Combination of Dabrafenib and Trametinib with or without Hydroxychloroquine in Patients with Stage IIIC or IV BRAF V600E / K Melanoma with Elevated LDH

    This phase II trial investigates how well adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib works to overcome resistance and delay disease progression in treating patients with stage IIIC or IV BRAF V600E / K melanoma with elevated lactate dehydrogenase (LDH). Hydroxychloroquine may cause cell death in tumor cells that rely on a process called "autophagy" for survival. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with dabrafenib and trametinib may work better than dabrafenib and trametinib alone to shrink and stabilize the cancer.
    Location: 83 locations

  • Dabrafenib, Trametinib, and Navitoclax in Treating Patients with BRAF Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

    This phase I / II trial studies the side effects and best dose of dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients with BRAF mutant melanoma or solid tumors that have spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). Dabrafenib, trametinib, and navitoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 37 locations

  • A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051 / KEYNOTE-051)

    This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of the following types of cancer: - advanced melanoma (6 months to <18 years of age), - advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant solid tumor or other lymphoma (6 months to <18 years of age), - relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age), or - advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6 months to <18 years of age), or - advanced relapsed or refractory tumor-mutational burden-high ≥10 mutation / Mb (TMB-H) solid tumors (6 months to <18 years of age) Part 1 will find the maximum tolerated dose (MTD) / maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D. The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL, will result in an Objective Response Rate (ORR) greater than 10% for at least one of these types of cancer. The 10% assessment does not apply to the MSI-H and TMB-H cohorts. With Amendment 8, enrollment of participants with solid tumors and of participants aged 6 months to <12 years with melanoma were closed. Enrollment of participants aged ≥12 years to ≤18 years with melanoma continues. Enrollment of participants with MSI-H and TMB-H solid tumors also continues.
    Location: 18 locations

  • An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

    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.
    Location: 21 locations

  • Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1 / 2 / 3 (Trk A / B / C), ROS1, or ALK Gene Rearrangements (Fusions)

    This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1 / 2 / 3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.
    Location: 18 locations

  • A Study to Evaluate The Efficacy And Safety Of RO7198457 In Combination With Pembrolizumab Versus Pembrolizumab Alone In Participants With Previously Untreated Advanced Melanoma.

    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.
    Location: 16 locations

  • Testing the Addition of Whole Brain Radiotherapy Using a Technique That Avoids the Hippocampus to Stereotactic Radiosurgery in Patients with Cancer That Has Spread to the Brain and Come Back in Other Areas of the Brain after Earlier Stereotactic Radiosurgery

    This phase III trial compares the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery. Hippocampus avoidance during whole-brain radiation therapy decreases the amount of radiation that is delivered to the hippocampus, which is a brain structure that is important for memory. The medicine memantine is also often given with whole brain radiation therapy because it may decrease the risk of side effects of radiation on neurocognitive function (including thinking and memory). Stereotactic radiosurgery delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Adding whole brain radiotherapy with hippocampal avoidance and memantine to stereotactic radiosurgery may be effective in reducing the size of the cancer or keeping the cancer the same size when it has spread to the brain and / or come back in other areas of the brain following stereotactic radiosurgery.
    Location: 15 locations

  • A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

    The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread
    Location: 16 locations

  • Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors

    This is a phase 1b / 2, open-label, two-part, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral cavrotolimod injections alone and in combination with intravenous pembrolizumab or cemiplimab in patients with Merkel Cell Carcinoma, cutaneous squamous cell carcinoma, and advanced solid tumors. Phase 1b of this trial is a 3+3 dose escalation study evaluating escalating or intermediate dose levels of cavrotolimod given with a fixed dose of pembrolizumab. The Phase 2 dose expansion part of the study will consist of two primary cohorts of patients: Merkel cell carcinoma and cutaneous squamous cell carcinoma. Patients in the Merkel Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of pembrolizumab while the Cutaneous Squamous Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of cemiplimab. The Phase 2 dose expansion is designed to provide a preliminary estimate of efficacy in patients that have progressed on an anti-PD-(L)1 CPI.
    Location: 15 locations

  • Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

    A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel) / LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel) / LN-145 / LN-145-S1 as a single agent therapy.
    Location: 14 locations

  • Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients

    This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will concurrently enroll patients with four distinct advanced malignancies in 5 separate tumor cohorts. The four cancers type are NSCLC and melanoma that are progressing on CPI treatment, CPI-naïve HCC, and treatment-naïve Endometrial.
    Location: 14 locations

  • Study of NGM120 in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy

    Study of NGM120 in subjects with advanced solid tumors and pancreatic cancer.
    Location: 13 locations

  • A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)

    This is a multicenter, open-label, first-in-human Phase 1 study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts: with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 as a single agent (Part 1a); in combination with anti-programmed cell death protein-1 (PD-1) antibody, nivolumab (Part 1b); in combination with anti-PD-1 antibody, TSR-042 (Part 1c); in combination with TSR-042 and anti-lymphocyte-activation gene 3 (LAG-3) antibody, TSR-033 (Part 1d); in combination with TSR-042 in participants not previously treated with programmed death-ligand 1 [PD-(L)1] (Part 1e) and in combination with docetaxel (Part 1f). Part 2 of the study will evaluate the antitumor activity of TSR-022, both as monotherapy and in combination with TSR-042 in participants with pre-specified tumor types.
    Location: 14 locations

  • Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB / C Melanoma

    The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB / C melanoma with no evidence of disease (NED) who are at high risk for recurrence.
    Location: 12 locations

  • A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)

    This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD / RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination therapy with ipilimumab in subjects with selected advanced solid tumors.
    Location: 11 locations

  • A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

    This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD / RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.
    Location: 11 locations

  • An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Patients With High-Risk Melanoma (KEYNOTE-942)

    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.
    Location: 11 locations


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