Clinical Trials for Melanoma

A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

Active drug

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

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.

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 advanced, recurrent, or metastatic solid tumors after standard therapy, an injectable tumor, and ECOG 0–1 receive intratumoral T3011 alone or with intravenous pembrolizumab; expansion cohorts include melanoma, head and neck or cutaneous squamous cell carcinoma, sarcoma, and EGFR/ALK-negative NSCLC. T3011 is an oncolytic HSV-1 engineered to lyse tumor cells and express IL-12 and an anti-PD-1 antibody fragment; pembrolizumab also blocks PD-1.

ClinicalTrials.gov ID: NCT04370587

Ulixertinib (BVD-523) in Combination With Palbociclib in Patients With Advanced Solid Tumors With Expansion Cohort in Previously Treated Metastatic Pancreatic Cancer and Metastatic RAS-mutant and NF1-mutant (no BRAFV600 Mutations) Melanoma

Active drug

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

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.

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 refractory advanced solid tumors receive oral ulixertinib, an ERK1/2 inhibitor, plus palbociclib, a CDK4/6 inhibitor. Expansion cohorts include previously treated metastatic pancreatic cancer and unresectable or metastatic RAS- or NF1-mutant melanoma without a BRAF V600 mutation; the pancreatic and all-solid-tumor cohorts are closed to enrollment.

ClinicalTrials.gov ID: NCT03454035

Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer/Germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors

Active drug

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

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.

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: Patients with recurrent or refractory solid tumors after standard treatment may be eligible if they are HLA-A*02:01-positive, have PRAME-expressing tumors and measurable disease, and have ECOG performance status 0–1. After lymphodepletion, they receive autologous T cells engineered with a receptor targeting PRAME presented by HLA-A*02:01 (IMA203 or CD8-enhanced IMA203CD8); some cohorts also receive IL-2 or, with IMA203, the PD-1 inhibitor nivolumab.

ClinicalTrials.gov ID: NCT03686124

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

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.

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 previously treated advanced solid tumors or T-cell lymphoma receive investigational BI-1808, a TNFR2-blocking antibody designed to reduce immunosuppressive regulatory T cells, either alone or with the anti-PD-1 antibody pembrolizumab. Expansion cohorts include ovarian cancer, T-cell lymphoma, melanoma, and selected solid tumors.

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.

TrialFetch 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

A Phase I/IIa, First-In-Human, Multi-Center, Monotherapy and Combination-Therapy With Nivolumab, Dose-Escalation and Dose-Expansion Study of [212Pb]VMT01 Melanocortin-1 Receptor-Targeted, Image-Guided Alpha-Particle Therapy in Subjects With Previously Treated Unresectable or Metastatic Melanoma

Active drug

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

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.

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 previously treated unresectable stage III or metastatic stage IV melanoma, ECOG 0–1, and tumor uptake on MC1R-targeted imaging receive investigational [212Pb]VMT01 alone or with nivolumab. [212Pb]VMT01 is an MC1R-binding peptide that delivers alpha-particle radiation to tumors; nivolumab is a PD-1 inhibitor.

ClinicalTrials.gov ID: NCT05655312

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.

TrialFetch 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 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.

TrialFetch 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 I Study Investigating the Safety of Stereotactic Body Radiotherapy (SBRT) With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma

Active drug

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

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.

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 advanced solid tumors progressing after standard therapy, or melanoma progressing after anti–PD-(L)1 therapy, receive organ-adapted SBRT to 1–4 tumor sites plus nivolumab (anti–PD-1) and investigational BMS-986253/adakitug (an IL-8–neutralizing antibody).

ClinicalTrials.gov ID: NCT04572451

Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory 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.

TrialFetch AI summary: Adults with unresectable stage III/IV non-ocular melanoma that has progressed on prior PD‑1/PD‑L1 therapy receive pembrolizumab plus metronomic oral cyclophosphamide (50 mg days 1–14 each 21‑day cycle). Rationale: anti–PD‑1 blockade (pembrolizumab) combined with low-dose cyclophosphamide, an alkylator with immunomodulatory Treg‑depleting effects, aims to overcome checkpoint inhibitor resistance; excludes uveal melanoma and uncontrolled CNS metastases.

ClinicalTrials.gov ID: NCT06771544