Clinical Trials for Melanoma

A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas

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.

TrialFetch AI summary: For adults with progressing, unresectable or recurrent advanced solid tumors or lymphomas who have no remaining standard treatment options and at least one injectable, measurable lesion, this study evaluates intratumoral ONM-501 alone or with cemiplimab. ONM-501 is an investigational STING-directed immunotherapy designed to enhance intracellular cGAMP delivery and sustain STING activation; cemiplimab inhibits PD-1.

ClinicalTrials.gov ID: NCT06022029

A Phase I/II, Open-label, Adaptive Two-part Trial to Evaluate the Safety, Efficacy, Optimal Dose and Pharmacokinetics of BNT326 as Monotherapy and in Combination With Cancer Immunotherapies in Participants With Advanced Solid Tumors

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.

TrialFetch AI summary: Adults with measurable advanced or recurrent solid tumors, including previously treated melanoma, NSCLC, and HER2-negative breast cancer, receive BNT326 (beruzatatug pelitecan), a HER3-directed antibody–drug conjugate carrying a topoisomerase-I inhibitor. Melanoma and HER2-negative breast cancer cohorts also evaluate BNT326 with BNT327 (pumitamig), a PD-L1/VEGF-A bispecific antibody.

ClinicalTrials.gov ID: NCT07070232

A Phase I/II Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6750, a CD8 Guided IL-2 Agent Alone and in Combination With Other Anti-cancer Agents in Participants With Select Advanced or Metastatic Solid Tumors

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.

TrialFetch AI summary: Adults with ECOG 0–1 and selected advanced or metastatic solid tumors receive AZD6750, an investigational CD8-guided IL-2 agent designed to preferentially stimulate CD8-positive T cells. A separate cohort of patients with stage IV NSCLC receives AZD6750 plus rilvegostomig, an investigational PD-1/TIGIT bispecific antibody.

ClinicalTrials.gov ID: NCT07115043

A Phase 1/2, Open-Label, Multi-Center, Dose Escalation and Expansion Study of KB707 in Subjects With Locally Advanced or Metastatic Solid Tumor 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.

TrialFetch AI summary: The enrolling cohorts are for patients with unresectable stage III or IV melanoma after anti-PD-1/PD-L1 therapy; those with BRAF V600–mutant disease must also have failed BRAF-directed treatment. Patients receive intratumoral KB707, a replication-defective HSV-1 vector designed to express IL-12 and IL-2 locally, plus either nivolumab/relatlimab (PD-1/LAG-3 blockade) or pembrolizumab (PD-1 blockade).

ClinicalTrials.gov ID: NCT05970497

A Phase I, Open Label Single-arm Two-part Study to Investigate Safety, Pharmacokinetics, and Preliminary Efficacy of Pan-RAF/MEK Glue NST-628 Oral Tablets in Subject With Solid Tumors Harboring Genetic Alterations in the MAPK Pathway and With Other Solid Tumors

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.

TrialFetch AI summary: Adults with advanced solid tumors lacking suitable standard treatment receive once-daily oral NST-628, an investigational pan-RAF–MEK molecular glue that blocks MAPK signaling. Dose escalation includes tumors with MAPK-pathway alterations or dependence; expansion focuses on selected NRAS-, KRAS-, or BRAF-altered tumors, including melanoma and glioma, and excludes patients previously treated with MEK or BRAF inhibitors.

ClinicalTrials.gov ID: NCT06326411

A Phase 2, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of V940 (mRNA-4157) Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With First-Line Advanced Melanoma (INTerpath-012)

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.

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 previously untreated, unresectable stage III or IV cutaneous melanoma are randomized to pembrolizumab plus V940 or pembrolizumab plus placebo. V940 is a personalized mRNA therapy encoding tumor neoantigens to stimulate tumor-directed T cells; pembrolizumab is an anti–PD-1 antibody.

ClinicalTrials.gov ID: NCT06961006

A First-in-human, Open-label Trial to Evaluate the Combination of ACTengine® IMA203 With mRNA-4203 in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma or Synovial Sarcoma Patients (ACTengine® IMA203-102)

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.

TrialFetch AI summary: This trial enrolls HLA-A*02:01-positive patients with previously treated, unresectable or metastatic cutaneous melanoma or synovial sarcoma; melanoma must have progressed on or after PD-1 inhibition. Patients receive autologous IMA203 T cells engineered to recognize HLA-A*02–presented PRAME, combined with dose-escalated mRNA-4203, which is designed to increase PRAME presentation and stimulate the engineered T cells.

ClinicalTrials.gov ID: NCT06946225

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies

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.

TrialFetch AI summary: Adults with ECOG 0–1 and advanced ER-positive/HER2-negative breast cancer harboring a PIK3CA, AKT1, or PTEN alteration after endocrine therapy, or unresectable/metastatic cutaneous melanoma after checkpoint inhibition, receive oral AMXT 1501 (a polyamine transport inhibitor) plus oral DFMO (an inhibitor of polyamine synthesis). The breast cancer cohort also receives fulvestrant and capivasertib; the melanoma cohort receives pembrolizumab.

ClinicalTrials.gov ID: NCT07287917

A Pilot Study of ctDNA-Guided Immune Checkpoint Inhibitor Duration in Patients With Advanced Melanoma.

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.

TrialFetch AI summary: Adults with unresectable stage III or IV melanoma and responding or stable disease after 6–12 months of anti-PD-1–based therapy, or a response requiring interruption for an immune-related adverse event, undergo tumor-informed ctDNA testing alongside imaging. Patients with confirmed undetectable ctDNA stop immunotherapy and are monitored; those with detectable ctDNA continue investigator-selected treatment.

ClinicalTrials.gov ID: NCT07830225

Phase I Study of MEM-288 Oncolytic Virus Alone and in Combination With Nivolumab in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)

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 ECOG 0–1, measurable disease, and an injectable, biopsy-accessible lesion may receive intratumoral MEM-288 alone after standard therapy for selected advanced solid tumors, or with nivolumab after first progression on frontline PD-1/PD-L1–based therapy for advanced NSCLC. MEM-288 is an oncolytic adenovirus designed to lyse tumor cells and express interferon beta and a CD40-ligand construct to stimulate antitumor immunity; nivolumab inhibits PD-1.

ClinicalTrials.gov ID: NCT05076760