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Clinical Trials for Melanoma

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There are 187 active trials for advanced/metastatic melanoma.

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187 trials meet filter criteria.

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High burden on patient More information Started >3 years ago More information
Sponsor: M.D. Anderson Cancer Center (other) Phase: 1 Start date: Nov. 22, 2017

HealthScout AI summary: Adolescents and adults (12–50) with histologically confirmed solid tumors metastatic to the lungs, ECOG ≤2 and adequate organ/pulmonary function, receive on‑site aerosolized gemcitabine via nebulizer twice weekly in 28‑day cycles, including those previously treated with systemic gemcitabine. Gemcitabine is a nucleoside analog prodrug that inhibits ribonucleotide reductase and DNA synthesis; trial excludes active asthma or significant pulmonary symptoms and seeks to define pulmonary MTD and preliminary activity.

ClinicalTrials.gov ID: NCT03093909

High burden on patient More information Started >3 years ago More information
Sponsor: National Cancer Institute (NCI) (federal) Phase: 2 Start date: Aug. 18, 2022

HealthScout AI summary: Adults with metastatic/unresectable melanoma (PD‑1–refractory or PD‑1–naïve) or metastatic clear‑cell RCC refractory to PD‑1/PD‑L1–based therapy receive pembrolizumab (PD‑1 blockade) combined with high‑dose aldesleukin/IL‑2 (T‑cell activation) given inpatient. Single‑arm design aims to improve objective response; excludes significant autoimmune disease, prior severe irAEs, active infection, or major cardiopulmonary compromise.

ClinicalTrials.gov ID: NCT05155033

No known activity More information High burden on patient More information
Sponsor: Regeneron Pharmaceuticals (industry) Phase: 1/2 Start date: Sept. 23, 2024

HealthScout AI summary: Adults with advanced/metastatic solid tumors after standard therapy receive REGN10597, an intravenously delivered anti–PD-1–IL2RA–IL2 fusion protein designed to target IL-2 signaling to PD-1–positive activated T cells while limiting systemic IL-2 effects; expansion cohorts enroll melanoma and clear-cell RCC. Key exclusions include prior IL-2/IL-15/IL-7 therapy, recent checkpoint inhibitors or systemic therapy, active immune-related AEs, significant autoimmune disease, or need for systemic immunosuppression.

ClinicalTrials.gov ID: NCT06413680

High burden on patient More information Started >3 years ago More information
Sponsor: Udai Kammula (other) Phase: 2 Start date: May 14, 2018

HealthScout AI summary: Adults with measurable metastatic uveal melanoma (ECOG 0–1), including those with small stable brain mets, receive nonmyeloablative lymphodepletion (cyclophosphamide/fludarabine) followed by a single infusion of autologous tumor-infiltrating lymphocytes and high‑dose IL‑2; TILs are expanded from a resected metastasis and act via tumor‑reactive T‑cell–mediated killing augmented by IL‑2. Key exclusions include active infection, significant autoimmune disease, uncontrolled cardiopulmonary disease, HIV/hepatitis, and systemic steroids.

ClinicalTrials.gov ID: NCT03467516

High burden on patient More information Started >3 years ago More information
Sponsor: H. Lee Moffitt Cancer Center and Research Institute (other) Phase: 2 Start date: Sept. 24, 2020

HealthScout AI summary: Adults with inoperable stage III/IV melanoma that has progressed after prior anti–PD-1 therapy (with prior BRAF-targeted therapy if BRAF V600+) receive high-dose bolus IL-2 (IL-2 receptor agonist) plus low-dose ipilimumab (anti–CTLA-4) followed sequentially by nivolumab (anti–PD-1), with up to three repeatable courses. Excludes active brain metastases and requires ECOG 0–1 and adequate cardiac/pulmonary function given HD IL-2 toxicity.

ClinicalTrials.gov ID: NCT04562129

High burden on patient More information Started >3 years ago More information
Sponsor: Merck Sharp & Dohme LLC (industry) Phase: 1/2 Start date: March 18, 2015

HealthScout AI summary: Pediatric trial of pembrolizumab (anti–PD-1 monoclonal antibody) monotherapy for children/adolescents with advanced melanoma (currently enrolling ages ≥12–≤18) and biomarker-selected solid tumors (MSI-H or TMB ≥10 mut/Mb), plus a cohort for relapsed/refractory classic Hodgkin lymphoma (ages 3–<18) and an adjuvant cohort for resected high-risk melanoma (ages 12–<18). Key exclusions include prior PD-1/PD-L1/CTLA-4 therapy and active CNS metastases or autoimmune disease; dosing is IV q3 weeks (2 mg/kg, max 200 mg).

ClinicalTrials.gov ID: NCT02332668

High burden on patient More information Started >3 years ago More information
Sponsor: Loyola University (other) Phase: 1 Start date: Feb. 1, 2015

HealthScout AI summary: Adults with HLA-A2–positive, tyrosinase-expressing metastatic melanoma (ECOG 0–1), including those progressed after checkpoint inhibitors and, if BRAF V600–mutant, after BRAF/MEK therapy, receive a single infusion of autologous T cells retrovirally engineered to express the 1383I TCR targeting tyrosinase/HLA-A2. Dose-escalation assesses safety/MTD and early activity signals; key exclusions include active/uncontrolled brain metastases, systemic steroids, significant organ dysfunction, and prior tyrosinase-directed immunotherapy.

ClinicalTrials.gov ID: NCT02870244

No known activity More information High burden on patient More information
Sponsor: Yale University (other) Phase: 1 Start date: Aug. 5, 2025

HealthScout AI summary: Enrolls adults with unresectable/metastatic melanoma progressing after PD‑1/PD‑L1 therapy and other checkpoint inhibitor–responsive solid tumors for AB821 monotherapy, an IV CD8‑IL21 fusion immunotherapy that selectively activates IL‑21 signaling in CD8+ T cells to enhance cytotoxicity and T‑cell memory. Patients must have ECOG 0–1 and adequate organ function; key exclusions include active autoimmune disease requiring treatment, untreated/unstable CNS metastases, significant cardiovascular disease, chronic immunosuppression, and prior IL‑21–based therapy.

ClinicalTrials.gov ID: NCT07027488

No known activity More information High burden on patient More information
Sponsor: Krystal Biotech, Inc. (industry) Phase: 1/2 Start date: Oct. 31, 2023

HealthScout AI summary: Enrolling adults (and ≥12 in one cohort) with unresectable stage III/IV melanoma that has progressed after anti–PD-1/PD-L1 therapy (and after BRAF±MEK for V600-mutant), excluding ocular or active CNS disease and >2 prior systemic lines. Intratumoral KB707, an oncolytic HSV-1 engineered to express IL-12 and IL-2, is given with checkpoint blockade (Opdualag or pembrolizumab) to enhance local/systemic antitumor immunity.

ClinicalTrials.gov ID: NCT05970497

No known activity More information High burden on patient More information
Sponsor: ModernaTX, Inc. (industry) Phase: 1 Start date: March 25, 2025

HealthScout AI summary: Adults with ECOG 0–1 and measurable advanced/metastatic solid tumors (broad tumor types) receive intramuscular mRNA-4106 monotherapy dose escalation; a separate cohort enrolls treatment‑naive unresectable/metastatic melanoma for mRNA-4106 combined with nivolumab/relatlimab. mRNA-4106 is a lipid‑nanoparticle mRNA vaccine encoding multiple shared tumor-associated antigens to prime/boost tumor‑specific T cells; the combo leverages PD‑1/LAG‑3 blockade.

ClinicalTrials.gov ID: NCT06880549

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