Clinical Trials for Melanoma

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

A Phase I/II Trial of Vemurafenib and Metformin to Unresectable Stage IIIC and Stage IV BRAF.V600E+ Melanoma Patients

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 stage IIIC–IV BRAF V600E–mutant melanoma (ECOG 0–2) receive vemurafenib (oral BRAF V600 inhibitor) combined with metformin (biguanide with AMPK/mTOR/tumor metabolism effects). Excludes prior vemurafenib or metformin intolerance; treatment is continuous 28-day cycles until progression or toxicity.

ClinicalTrials.gov ID: NCT01638676

A Single and Repeat Dosing and Expansion Study of the Safety, Drug Exposure and Clinical Activity of R-5780 in Combination With a PD-1 (Checkpoint Protein on Immune Cells Called T Cells) Pathway Checkpoint Inhibitor in Patients With Solid Tumors

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Adults with unresectable stage III/IV solid tumors (e.g., melanoma, BCC, SCC) refractory to prior anti–PD‑1/PD‑L1 therapy receive an oral, precision‑engineered live biotherapeutic (R‑5780) added to their ongoing PD‑1 pathway inhibitor. R‑5780 is designed to modulate gut–immune pathways to enhance anti‑tumor T‑cell responses and potentiate checkpoint inhibition; key exclusions include recent broad‑spectrum antibiotics, active infections, significant autoimmune disease, untreated brain mets, and >4 prior systemic therapies.

ClinicalTrials.gov ID: NCT06398418

A Phase I/II Study of Tebentafusp-tebn in Combination With Liver-Directed Therapies for the Treatment of Metastatic Uveal 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: Enrolling HLA-A*02:01–positive adults with metastatic uveal melanoma involving the liver (≥1 measurable liver lesion), ECOG 0–1; Part 1 focuses on low–moderate hepatic burden and no prior systemic therapy in the metastatic setting, while Part 2 includes bulky liver-dominant disease (largest lesion >5 cm and/or ≥50% liver involvement) and allows up to 2 prior systemic/liver-directed lines (excluding prior tebentafusp and prior chemoembolization). Patients receive weekly step-up tebentafusp-tebn (gp100/HLA-A*02:01–directed ImmTAC that redirects T cells via anti-CD3) alone or combined with hepatic immunoembolization plus GM-CSF (randomized vs tebentafusp alone in Part 1B), or sequential BCNU (carmustine) transarterial chemoembolization followed by tebentafusp in bulky disease (Part 2).

ClinicalTrials.gov ID: NCT06626516

Phase 2 Sequential Treatment With Melphalan/HDS Via Percutaneous Hepatic Perfusion Followed by Tebentafusp in the Treatment of Metastatic Uveal 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: Eligible patients are adults with ECOG 0–1, HLA-A*02:01–positive metastatic uveal melanoma with liver-dominant disease (≤50% liver replacement) and at least one measurable hepatic lesion, with significant extrahepatic disease largely excluded. Treatment is two sequential percutaneous hepatic perfusions delivering high-dose melphalan with extracorporeal hemofiltration 6–8 weeks apart, followed by up to 1 year of weekly tebentafusp (a gp100 peptide–HLA-directed TCR/anti-CD3 bispecific that redirects T cells to gp100-expressing melanoma cells), with additional PHP allowed on progression as standard of care.

ClinicalTrials.gov ID: NCT07276386

Phase I/II Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (TIL) for Patients With Advanced 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: Adults with unresectable stage III/IV or metastatic melanoma (cutaneous/acral; plus a cohort for mucosal or uveal), ECOG 0–1, progressed after at least one standard systemic therapy (e.g., anti–PD-1/L1; BRAF±MEK if BRAF V600-mutant), with an accessible lesion for harvest and stable treated brain metastases allowed. Patients undergo tumor resection for manufacturing, lymphodepleting cyclophosphamide/fludarabine, then a single infusion of autologous CD40L-augmented tumor-infiltrating lymphocytes (CD40 ligand signaling to enhance APC activation/costimulation) followed by short-course bolus aldesleukin (IL-2) support.

ClinicalTrials.gov ID: NCT06961357