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.

HealthScout AI summary: This trial involves adult patients with advanced solid tumors who have limited treatment options, evaluating the efficacy and safety of IBI363, a PD-1/IL-2α-bias bispecific antibody fusion protein targeting the PD-1/PD-L1 pathway and activating the IL-2 pathway to enhance tumor-specific T cell activity.

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.

HealthScout AI summary: Adults with unresectable/metastatic melanoma (including mucosal/unknown primary; treatment-naïve allowed) or recurrent/metastatic HNSCC after platinum therapy are randomized to pembrolizumab plus GB1211 vs pembrolizumab plus placebo. GB1211 (selvigaltin) is an oral selective galectin‑3 inhibitor aimed at reversing immune suppression and resistance to PD‑1 blockade; prior PD‑1/PD‑L1 allowed if ≥6 months since last dose with progression; key exclusions include active autoimmune disease and untreated brain mets.

ClinicalTrials.gov ID: NCT05913388

A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations

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.

HealthScout AI summary: Enrolling patients ≥10 years (≥30 kg) with unresectable/metastatic solid tumors or recurrent/progressive primary CNS tumors harboring qualifying BRAF alterations (class 1 V600E or class 2 incl. fusions), across cohorts for BRAF fusions, V600E CNS tumors, and selected rare V600E non‑CNS tumors; excludes NF1/activating RAS and prior MAPK inhibitors in most cohorts. Treatment is oral plixorafenib (PLX‑8394), a selective BRAF inhibitor that disrupts RAF dimer signaling and avoids paradoxical ERK activation, given alone or with cobicistat boosting depending on cohort.

ClinicalTrials.gov ID: NCT05503797

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.

HealthScout AI summary: Adults and adolescents (≥12) with unresectable stage IIIb–IV cutaneous melanoma progressing after anti–PD-1 and anti–CTLA-4 (with measurable, injectable lesions) are randomized to intratumoral vusolimogene oderparepvec (RP1), an engineered HSV‑1 oncolytic immunotherapy expressing GM‑CSF and GALV‑GP R-, plus nivolumab versus physician’s choice (Opdualag, anti–PD‑1 monotherapy, or single‑agent chemotherapy). Excludes mucosal/uveal melanoma, active CNS mets, >2 prior systemic lines, high LDH, significant autoimmune/infectious risks, or prior oncolytic/intratumoral therapy.

ClinicalTrials.gov ID: NCT06264180

A Phase II Study of IO102/IO103 and Nivolumab-relatlimab Fixed Dose Combination in Untreated, Unresectable Stage III/IV 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.

HealthScout AI summary: Untreated adults with unresectable stage III or metastatic stage IV cutaneous/subcutaneous melanoma (ECOG 0–1), including those relapsing >6 months after adjuvant/neoadjuvant ICI or BRAF/MEK, receive fixed-dose nivolumab–relatlimab (PD-1/LAG-3) plus IO102/IO103, an off‑the‑shelf long‑peptide vaccine targeting IDO1 and PD-L1 to prime tumor‑specific T cells. Excludes uveal melanoma and active/untreated CNS disease; treated, asymptomatic brain metastases allowed.

ClinicalTrials.gov ID: NCT05912244

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.

HealthScout AI summary: Adults with unresectable stage III/IV or metastatic cutaneous or mucosal melanoma that has progressed on prior PD-1/PD-L1 therapy (including after PD-1+LAG-3) receive triplet immune checkpoint blockade: fianlimab (anti–LAG-3), cemiplimab (anti–PD-1), and ipilimumab (anti–CTLA-4). Excludes uveal melanoma and untreated/leptomeningeal CNS disease; definitively treated brain metastases allowed.

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.

HealthScout AI summary: Adults with unresectable metastatic uveal melanoma, ECOG 0–1, ICI-naïve, and with at least one measurable/injectable lesion are randomized to intratumoral RP2 plus nivolumab versus standard ipilimumab plus nivolumab. RP2 is a replication-competent HSV‑1 oncolytic immunotherapy engineered to express GALV-GP-R−, GM-CSF, and a local anti–CTLA-4–like molecule to promote oncolysis and immune activation alongside PD-1 blockade.

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.

HealthScout AI summary: Adults with unresectable stage III–IV melanoma that is primary/acquired PD‑1/L1–refractory and has at least one injectable cutaneous/subcutaneous/nodal lesion (including treated, stable brain mets allowed) are randomized to pembrolizumab plus intratumoral L19IL2, L19TNF, or their combination. L19IL2 (IL‑2 fused to L19 antibody) and L19TNF (TNF‑α fused to L19) target the ED‑B domain of fibronectin to concentrate cytokines in tumor vasculature/ECM, aiming to convert PD‑1–refractory disease to responsive.

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.

HealthScout AI summary: Previously untreated adults with unresectable stage III/IV, HLA‑A*02:01–positive melanoma (ECOG 0–1, known BRAF status) are randomized to brenetafusp (IMC‑F106C), a PRAME‑directed soluble TCR/CD3 bispecific (ImmTAC) that redirects T‑cell cytotoxicity, plus nivolumab vs standard nivolumab or nivolumab/relatlimab. Excludes prior systemic therapy for advanced disease and active/untreated CNS mets; primary endpoint is PFS.

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.

HealthScout AI summary: Adults with unresectable stage III/IV melanoma eligible for first-line pembrolizumab (ECOG 0–1; non-ocular; no prior systemic therapy for advanced disease) are randomized to pembrolizumab plus EIK1001 vs pembrolizumab plus placebo. EIK1001 is an IV dual TLR7/8 agonist that activates dendritic cells to enhance innate and adaptive antitumor immunity, aiming to improve PFS/OS over pembrolizumab alone.

ClinicalTrials.gov ID: NCT06697301