Clinical Trials for Melanoma

Phase I Study of Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable stage III/IV melanoma that has progressed on prior PD-1/PD-L1 therapy receive lymphodepletion followed by a single infusion of cytokine-induced memory-like NK cells (autologous or haploidentical donor), then nivolumab (PD-1 inhibitor) plus relatlimab (LAG-3 antibody). Allows treated/stable brain metastases; excludes active autoimmune disease requiring immunosuppression, prior severe irAEs leading to permanent ICI discontinuation, TIL therapy, organ allograft, and active viral infections.

ClinicalTrials.gov ID: NCT05629546

A Randomized Phase 2 Trial of Ipilumumab and Nivolumab With or Without Hypofractionated Radiotherapy in Patients With Metastatic Melanoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with metastatic melanoma (ECOG 0–1) with at least two measurable lesions and one lesion amenable to hypofractionated radiotherapy are randomized to receive standard ipilimumab (anti–CTLA-4) plus nivolumab (anti–PD-1) with or without HFRT (8 Gy × 3 to a single lesion). Excludes active CNS disease requiring urgent therapy, prior checkpoint inhibitors in the metastatic setting, significant autoimmune disease/immunosuppression, active infections, or HFRT contraindications.

ClinicalTrials.gov ID: NCT03646617

Phase II Study of Binimetinib With Encorafenib in Patients With Metastatic Melanoma and CNS Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with BRAFV600-mutant metastatic melanoma with active CNS involvement (parenchymal and/or leptomeningeal) receive high-dose encorafenib (BRAF inhibitor) plus binimetinib (MEK1/2 inhibitor); includes two cohorts: prior BRAF/MEK–treated with progressive CNS disease and BRAF/MEK–naive, with prior immunotherapy allowed. Aims to evaluate intracranial disease control and PFS with continuous oral therapy; key exclusions include significant cardiovascular disease, recent thromboembolism, and strong CYP3A modulators.

ClinicalTrials.gov ID: NCT05026983

Phase 2 Study of Axitinib + PD-1 Blockade in Mucosal Melanoma With Pilot Addition of Stereotactic Body Radiotherapy or Ipilimumab in Select Progressors

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with unresectable or metastatic mucosal melanoma (head/neck including conjunctival, GI, or GU), treatment-naive, ECOG 0–2, including selected patients with brain metastases, receive nivolumab (PD-1 inhibitor) plus axitinib (VEGFR1–3 TKI); at progression, patients may continue doublet with SBRT for oligoprogression or add ipilimumab (CTLA-4 inhibitor) for multifocal/non-SBRT-amenable progression. Primary endpoint is objective response by RECIST 1.1 within 1 year.

ClinicalTrials.gov ID: NCT05384496

A Phase II Trial of Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with metastatic uveal melanoma (ECOG 0–1) receive pembrolizumab (anti–PD‑1) plus olaparib (PARP1/2 inhibitor) until progression or toxicity; prior liver-directed therapy allowed, but prior PD‑1/PD‑L1 or PARP inhibitors for uveal melanoma are excluded. Aims to test whether PARP inhibition can potentiate PD‑1 blockade in this population; key exclusions include uncontrolled CNS metastases and active autoimmune disease requiring systemic therapy.

ClinicalTrials.gov ID: NCT05524935

A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with untreated metastatic cutaneous melanoma starting standard PD-1 monotherapy or PD-1 plus CTLA-4 receive a single booster of tetanus-diphtheria or inactivated polio vaccine given near the largest tumor at cycle 4 to trigger immune recall and potentially enhance checkpoint efficacy. Excludes uveal/mucosal melanoma and significant immunosuppression; requires biopsy-amenable lesion and adequate counts.

ClinicalTrials.gov ID: NCT05077137

Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Adults with unresectable/metastatic melanoma that is relapsed/refractory to prior PD-1–based checkpoint therapy (HLA-A*02:01 positive, ECOG 0–1) receive lymphodepleting cyclophosphamide/fludarabine followed by a single infusion of PRAME-TCR-NK cells. PRAME-TCR-NK is an allogeneic NK cell product engineered with a TCR targeting PRAME presented by HLA-A*02:01 to enhance antigen-specific cytotoxicity; uveal melanoma may be enrolled in expansion.

ClinicalTrials.gov ID: NCT06660420

A Randomized Pilot Trial of Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib and Binimetinib in Advanced Melanoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with resectable stage IIIB–IV BRAFV600-mutant melanoma receive uniform neoadjuvant encorafenib (BRAF inhibitor) plus binimetinib (MEK inhibitor) for 24 weeks followed by surgery; adjuvant therapy is randomized by pathologic response: pCR to surveillance vs continued encorafenib/binimetinib, and non‑pCR to encorafenib/binimetinib vs nivolumab (PD‑1 inhibitor). Prior BRAF/MEK or checkpoint therapy allowed if criteria met; key exclusions include active/uncontrolled brain metastases and significant cardiac/ocular risks.

ClinicalTrials.gov ID: NCT04741997

A Phase 3, Multicenter, Randomized, Open-label, Parallel Group, Treatment Study to Assess the Efficacy and Safety of the Lifileucel (LN-144, Autologous Tumor Infiltrating Lymphocytes [TIL]) Regimen in Combination With Pembrolizumab Compared With Pembrolizumab Monotherapy in Participants With Untreated, Unresectable or Metastatic Melanoma

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

TrialFetch AI summary: Previously untreated adults with unresectable or metastatic cutaneous melanoma (AJCC IIIC–IV, ECOG 0–1) are randomized to pembrolizumab alone versus pembrolizumab plus lifileucel, an autologous tumor-infiltrating lymphocyte therapy infused after lymphodepleting chemotherapy (with post-infusion IL-2) that provides polyclonal tumor‑reactive T cells to augment antitumor cytotoxicity; crossover to lifileucel is allowed at BICR-confirmed progression. Excludes uveal melanoma and symptomatic untreated brain mets; prior adjuvant/neoadjuvant PD‑1/CTLA‑4/BRAF±MEK allowed if completed ≥6 months before metastatic progression.

ClinicalTrials.gov ID: NCT05727904

Phase 2 Study of Axitinib + Ipilimumab in Advanced Melanoma

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with unresectable or metastatic non-uveal melanoma who are refractory/intolerant to prior anti–PD-1/PD-L1 therapy (including relapse within 6 months of adjuvant), ECOG 0–2, and no prior ipilimumab, receive ipilimumab plus axitinib. Ipilimumab is a CTLA-4 checkpoint inhibitor and axitinib is an oral VEGFR-1/2/3 TKI; treated/stable brain metastases and prior BRAF/MEK inhibitors are allowed, while active autoimmune disease needing systemic therapy is excluded.

ClinicalTrials.gov ID: NCT04996823