Clinical Trials for Melanoma

A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with advanced, refractory solid tumors and ECOG performance status 0–1 receive intravenous IBI363 every 2 or 3 weeks. IBI363 is an investigational PD-1/IL-2α-biased fusion protein designed to combine PD-1 blockade with IL-2 signaling directed preferentially toward PD-1-positive T cells.

ClinicalTrials.gov ID: NCT06281678

Randomized Double-Blind Placebo Controlled Phase II Study of a Galectin-3 Inhibitor (GB1211) and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with unresectable or metastatic melanoma, or recurrent or metastatic head and neck squamous cell carcinoma that progressed during or after platinum chemotherapy, receive pembrolizumab plus either oral GB1211 or placebo. GB1211 is an investigational galectin-3 inhibitor; pembrolizumab targets PD-1.

ClinicalTrials.gov ID: NCT05913388

Randomized, Ph3 Clinical Study Comparing Vusolimogene Oderparepvec in Combination With Nivolumab Vs Treatment of Physician's Choice in Patients With Advanced Melanoma That Progressed on Anti-PD-1 and Anti-CTLA-4 Containing Treatment

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Patients aged 12 years or older with unresectable stage IIIB–IV cutaneous melanoma and an injectable lesion are randomized after progression on anti-PD-1 and anti-CTLA-4 therapy; patients ineligible for anti-CTLA-4 therapy may also enroll. Intratumoral vusolimogene oderparepvec, an oncolytic HSV-1 engineered to express GM-CSF and a fusogenic protein, plus nivolumab is compared with physician’s choice of nivolumab–relatlimab, anti-PD-1 monotherapy, or single-agent chemotherapy.

ClinicalTrials.gov ID: NCT06264180

A Phase 2 Study of Fianlimab, Cemiplimab, and Ipilimumab in Anti-PD-1 Refractory Melanoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with unresectable or metastatic cutaneous or mucosal melanoma progressing after PD-1 monotherapy or PD-1/LAG-3 blockade receive fianlimab (investigational anti–LAG-3), cemiplimab (anti–PD-1), and ipilimumab (anti–CTLA-4). Patients must have ECOG 0–1; untreated CNS metastases and uveal melanoma are excluded.

ClinicalTrials.gov ID: NCT06594991

A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab Versus Ipilimumab in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with checkpoint inhibitor–naïve, unresectable metastatic uveal melanoma, ECOG 0–1, and a measurable tumor accessible for repeated injection receive intratumoral RP2 plus nivolumab or ipilimumab plus nivolumab. RP2 is an engineered oncolytic HSV-1 that replicates in tumors and expresses a fusogenic protein, GM-CSF, and an anti–CTLA-4 antibody to stimulate antitumor immunity.

ClinicalTrials.gov ID: NCT06581406

A Phase 2, Three-arm, Randomized Study of the Efficacy of Intratumorally Administered L19IL2 or L19TNF or L19IL2/L19TNF, All in Combination with Systemic Anti-PD1 Pembrolizumab, in Stage III and IV Unresectable Melanoma Patients with Resistance to or Progressing Upon Anti-PD1 Checkpoint Inhibitors and with Presence of Injectable Metastases

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with ECOG 0–1, unresectable stage IIIB–IV melanoma progressing after anti-PD-1/PD-L1 therapy, and at least one injectable metastasis are randomized to pembrolizumab rechallenge plus intralesional L19IL2, L19TNF, or both. L19IL2 and L19TNF are IL-2 and TNF fusion proteins that target the extra-domain B of fibronectin to concentrate cytokine activity at tumors.

ClinicalTrials.gov ID: NCT06284590

A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with HLA-A*02:01-positive, unresectable stage III or IV melanoma and no prior systemic therapy for advanced disease are randomized to brenetafusp plus nivolumab or nivolumab alone or with relatlimab. Brenetafusp is an investigational bispecific T-cell engager that binds PRAME peptides presented by HLA-A*02:01 and CD3 to redirect T cells toward tumor cells.

ClinicalTrials.gov ID: NCT06112314

A Multicenter, Randomized, Double-Blind, Active Comparator-Controlled, Adaptive Phase 2/3 Study to Evaluate the Safety and Efficacy of EIK1001 and Pembrolizumab Versus Placebo and Pembrolizumab as First-Line Therapy in Participants With Advanced Melanoma (TeLuRide-006)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with previously untreated unresectable stage III or metastatic stage IV melanoma, measurable disease, and ECOG performance status 0–1 receive first-line pembrolizumab plus either placebo or EIK1001. EIK1001 is an investigational intravenous TLR7/8 agonist intended to enhance innate immune activation and tumor-specific T-cell priming.

ClinicalTrials.gov ID: NCT06697301

A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: For patients with previously untreated unresectable stage III or metastatic melanoma and ECOG performance status 0–1, this trial compares fixed-dose fianlimab plus cemiplimab with relatlimab plus nivolumab. Fianlimab is an investigational anti–LAG-3 antibody; cemiplimab blocks PD-1.

ClinicalTrials.gov ID: NCT06246916

A Multicenter, Open-Label, Randomized, Controlled Study to Assess the Antitumor Activity of LNS8801 With and Without Pembrolizumab in Patients With Treatment-Refractory, Unresectable Melanoma

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Patients with unresectable or metastatic cutaneous melanoma that has progressed after anti–PD-1 therapy, ECOG 0–1, and the required GPER C/C genotype are randomized to oral LNS8801, LNS8801 plus pembrolizumab, or physician’s choice of chemotherapy or immunotherapy. LNS8801 is an investigational GPER agonist with preclinical antiproliferative activity.

ClinicalTrials.gov ID: NCT06624644