Clinical Trials for Melanoma

Phase 1/2a Open-Label, Dose-Escalation, Multicenter, FIH, Consecutive-Cohort, Clinical Trial of BI-1808, a Monoclonal Antibody to TNFR 2 As a Single Agent and in Combination with Pembrolizumab (MK-3475-D20) in Subjects with Advanced Malignancies

Active drug

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

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.

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.

HealthScout AI summary: Adults with advanced solid tumors or T‑cell lymphomas (including CTCL) after failure/intolerance of standard therapy, ECOG 0–1, measurable disease, and biopsy‑amenable tumors receive BI‑1808, a human IgG1 anti‑TNFR2 antibody that blocks TNF‑α/TNFR2 signaling and may deplete TNFR2+ Tregs, given IV every 3 weeks as monotherapy or combined with pembrolizumab. Excludes active CNS metastases, significant autoimmune disease, recent anticancer therapy, or active infections; expansion cohorts include ovarian cancer, melanoma, and T‑cell lymphomas.

ClinicalTrials.gov ID: NCT04752826

Phase II Open-label, Multi-center Study of Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma (mUM) With Integrated Circulating Tumor DNA (ctDNA) Biomarker (TARGET-tebe)

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: HLA-A*02:01–positive adults with previously untreated metastatic uveal melanoma receive weekly tebentafusp (step-up to 68 mcg), a bispecific gp100–HLA-directed ImmTAC that redirects T cells via anti-CD3 to melanoma cells. The trial integrates serial Signatera ctDNA monitoring to correlate early molecular response with clinical outcomes.

ClinicalTrials.gov ID: NCT06070012

Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)

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: HLA-A*02:01–positive adults with unresectable stage III/IV non-ocular melanoma who have progressed after anti–PD-(L)1 (and received anti–CTLA-4; BRAF V600+ must have had BRAF/MEK) are randomized to tebentafusp alone, tebentafusp plus pembrolizumab, or investigator’s choice. Tebentafusp is an ImmTAC TCR–bispecific targeting gp100/HLA-A*02:01 and engaging CD3 to redirect T cells; the study excludes uveal melanoma and patients with active CNS metastases or significant autoimmune disease.

ClinicalTrials.gov ID: NCT05549297

A Phase I Study to Evaluate the Safety of Naltrexone and Propranolol in Combination With Standard of Care Ipilimumab and Nivolumab in Patients With 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.

HealthScout AI summary: Adults with unresectable stage III/IV melanoma eligible for ipilimumab 3 mg/kg plus nivolumab 1 mg/kg, ECOG 0–1, measurable disease, and no unstable brain mets or active autoimmune disease receive standard IPI+NIVO with propranolol (nonselective beta-adrenergic blocker) and escalating-dose naltrexone (opioid receptor antagonist) to test safety and define the recommended naltrexone dose. Prior systemic therapy is allowed with washout; patients requiring opioids are excluded from naltrexone cohorts.

ClinicalTrials.gov ID: NCT05968690

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.

HealthScout 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

Randomized Phase 2 Studying the Effects of Nicotinamide in Patients With Chronic Lymphocytic Leukemia (CLL) With History of Non-melanoma Skin Cancers (NMSC)

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to 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.

HealthScout AI summary: Adults with CLL/SLL who have had at least one NMSC in the past 5 years are randomized to oral nicotinamide 500 mg twice daily vs placebo for 12 months (then all receive nicotinamide in year 2) to prevent new NMSC. Nicotinamide (vitamin B3 amide) replenishes NAD+ to support DNA repair and reduce UV-induced immunosuppression in skin; key exclusions include recent cytotoxic therapy, current nicotinamide/niacin or recent retinoid use, significant drug interactions, and solid-organ transplant on immunosuppression.

ClinicalTrials.gov ID: NCT04844528

A Phase 1, Open-Label, Dose-Escalation With Expansion Study of SX-682 in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab

Active drug

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

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.

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.

HealthScout AI summary: Adults with unresectable stage III/IV melanoma (including mucosal, excluding ocular) who have progressed on prior anti–PD-1/PD-L1 therapy receive the oral CXCR1/2 inhibitor SX‑682 (blocks myeloid-derived suppressor cell recruitment) with a short monotherapy lead‑in followed by combination with fixed‑dose pembrolizumab. Eligible patients must have measurable non‑CNS disease, ECOG 0–1, and may have treated/stable brain metastases; key risks include neutropenia.

ClinicalTrials.gov ID: NCT03161431

A Phase II Study of Cemiplimab Plus Ziv-Aflibercept for Subjects With Metastatic 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.

HealthScout AI summary: Adults with metastatic uveal melanoma (treatment-naive or previously treated) without prior cemiplimab, bevacizumab, or aflibercept receive cemiplimab (PD-1 inhibitor) plus ziv-aflibercept (VEGF/PlGF trap anti-angiogenic) to test response; a separate cohort includes metastatic cutaneous/mucosal/unknown-primary melanoma progressed after anti–PD-1 (BRAF V600 must have used/declined targeted therapy). Key requirements include ECOG 0–1, measurable disease, adequate organ function, and no active brain mets or significant autoimmune/cardiovascular contraindications.

ClinicalTrials.gov ID: NCT06121180

Phase 1B Trial of AV-MEL-1 (Autologous Dendritic Cells Loaded With Autologous Tumor Antigens) With Anti-PD-1 Checkpoint Inhibitors in Metastatic Melanoma

Active drug

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

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.

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.

HealthScout AI summary: Adults with metastatic melanoma who have a resectable lesion for tumor procurement and are candidates for anti–PD-1 therapy (including both treatment-naive and those previously treated with PD-1 ± CTLA-4 or BRAF/MEK inhibitors) receive standard pembrolizumab or nivolumab with subsequent addition of AV-MEL-1, an autologous dendritic-cell vaccine loaded with patient-specific tumor antigens plus GM-CSF. The study evaluates safety and preliminary efficacy of combining PD-1 blockade with this personalized DC vaccine intended to enhance T-cell–mediated antitumor immunity.

ClinicalTrials.gov ID: NCT03743298

A Phase II Study of Core Needle Biopsy and Cryoablation of an Enlarging Tumor in Patients With Advanced Melanoma Receiving Post-progression Dual Immune Checkpoint Inhibitor 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.

HealthScout AI summary: Adults with unresectable/metastatic melanoma that has progressed on prior PD‑1–based therapy receive standard ipilimumab (CTLA‑4 inhibitor) plus nivolumab (PD‑1 inhibitor) combined with image‑guided core biopsy and percutaneous cryoablation of one enlarging lesion between cycles 1 and 2. Allows asymptomatic brain metastases and controlled HIV/HBV/HCV; requires at least one measurable non‑ablated lesion and one lesion amenable to cryoablation.

ClinicalTrials.gov ID: NCT05779423