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

Randomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients With Unresectable Stage III or Stage IV 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 stage III–IV melanoma (ECOG 0–1, measurable disease, no active CNS mets; no prior PD‑1/PD‑L1 or CTLA‑4 in metastatic setting) are randomized to nivolumab (PD‑1 inhibitor) plus ipilimumab (CTLA‑4 antibody) with or without sargramostim/GM‑CSF (dendritic cell/myeloid activator) during induction and continued maintenance (nivolumab ± GM‑CSF) for up to 2 years. The trial tests whether adding GM‑CSF improves overall survival and tolerability versus the standard nivolumab/ipilimumab regimen.

ClinicalTrials.gov ID: NCT02339571

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

A Phase II Study of PD-1 Blockade With or Without LAG-3 Inhibition in Combination With Infliximab for the Treatment of Metastatic Melanoma and Prevention of Adverse Events

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 III/IV cutaneous metastatic melanoma starting first-line PD-1–based therapy (pembrolizumab or nivolumab+relatlimab [LAG-3 inhibitor]) are randomized to receive prophylactic infliximab (anti–TNF-α mAb) versus placebo. The trial tests whether short-course TNF-α blockade reduces early immune-related adverse events without compromising antitumor efficacy.

ClinicalTrials.gov ID: NCT05034536

A Phase II Study of the Interleukin-6 Receptor Inhibitor Sarilumab in Combination With Ipilimumab, Nivolumab and Relatlimab in Patients With Unresectable Stage III or Stage IV 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 cutaneous melanoma (non-uveal), treatment-naïve for metastatic disease, receive ipilimumab plus fixed-dose nivolumab/relatlimab with added sarilumab, an interleukin‑6 receptor–blocking antibody intended to mitigate immune-related toxicity and potentially enhance efficacy. Excludes active/untreated brain metastases, active autoimmune disease requiring systemic therapy, and significant immunosuppression.

ClinicalTrials.gov ID: NCT05428007

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