Clinical Trials for Melanoma

PRIME-LRT: PRomoting IMmunotherapy Efficacy With Low-Dose Liver RT

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: Enrolls adults with biopsy-proven NSCLC (excluding EGFR/ALK/ROS1/RET-altered tumors) or melanoma with radiographic liver metastases, ECOG 0–2, eligible for standard PD-1/PD-L1 checkpoint inhibitor–based therapy (± chemotherapy and/or CTLA-4 inhibition per routine practice). All patients receive standard systemic therapy plus investigational low-dose liver radiation delivered in the week before cycles 1, 2, and 3 to potentially modulate the hepatic immune microenvironment and enhance checkpoint inhibitor efficacy.

ClinicalTrials.gov ID: NCT07225036

The TIME Trial - Phase II Randomized Controlled Trial of Time-of-Day Specified Immunotherapy for 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.

TrialFetch AI summary: Adults with previously untreated unresectable/metastatic AJCC 8th stage IV cutaneous, acral, or mucosal melanoma (uveal excluded), ECOG 0–1, including eligible small asymptomatic non-hemorrhagic brain metastases, receive standard nivolumab (PD-1 inhibitor) plus ipilimumab (CTLA-4 inhibitor) induction q3w ×4 followed by nivolumab maintenance up to 2 years. Patients are randomized to have each cycle’s infusion start in a fixed morning (08:00–11:00), mid-day (11:00–14:00), or afternoon (14:00–17:00) window to test whether time-of-day affects outcomes/toxicity.

ClinicalTrials.gov ID: NCT07155317

A Pilot Study of Mirdametinib in Patients With Advanced Melanoma With an NF1 Mutation

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 adults with unresectable or metastatic melanoma harboring a pathogenic NF1 mutation and RECIST-measurable progression after prior immune checkpoint inhibitor therapy (anti–PD-1/PD-L1, typically also anti–CTLA-4 and/or anti–LAG3), this single-center study treats patients with oral mirdametinib, a MEK inhibitor targeting MAPK signaling downstream of RAS. Mirdametinib is given twice daily continuously in 28-day cycles until progression or unacceptable toxicity, excluding patients with prior MEK/ERK/RAF inhibitors or symptomatic/steroid-requiring brain metastases.

ClinicalTrials.gov ID: NCT07237100

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

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: This clinical trial evaluates the safety and efficacy of the investigational drug NEO212, a novel conjugate of temozolomide and perillyl alcohol with enhanced brain penetration, in adults with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, or uncontrolled brain metastases from select solid tumors, including combinations with standard treatments like pembrolizumab or ipilimumab.

ClinicalTrials.gov ID: NCT06047379

A Feasibility Multicenter Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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 adults (ECOG 0-2) with locally advanced or metastatic cancers eligible for atezolizumab, investigating therapeutic drug monitoring-based personalized dosing of atezolizumab (anti-PD-L1 immune checkpoint inhibitor) as monotherapy or combined with other approved agents. Patients initially receive standard dosing, then transition to adaptive, lower-frequency fixed dosing based on plasma levels.

ClinicalTrials.gov ID: NCT06066138

Open-label, Non-randomized, Multi-cohort, Phase 1b/2 Trial Investigating the Safety, Tolerability, and Antitumor Activity of STC-15 (a METTL3 Inhibitor) as a Part of Combination Therapy With Toripalimab in Participants With Selected Advanced Cancers

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 adults with advanced or metastatic NSCLC, melanoma, endometrial cancer, or HNSCC who have progressed after standard therapies including prior anti-PD-1/L1 agents, and evaluates the combination of STC-15 (an oral METTL3 inhibitor targeting RNA methylation) plus toripalimab (anti-PD-1 antibody). Eligible patients must have measurable disease, ECOG 0–1, and no active CNS disease.

ClinicalTrials.gov ID: NCT06975293

Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)

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 adults with advanced or metastatic melanoma (including those with untreated brain metastases) or triple-negative breast cancer with brain metastases who have progressed after standard therapy, testing the combination of alpelisib (a PI3Kα inhibitor) and pembrolizumab (a PD-1 inhibitor).

ClinicalTrials.gov ID: NCT06545682

Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors

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.

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: This trial enrolls adults with locally advanced or metastatic non-GIST solid tumors (such as melanoma, sarcoma, or primary CNS tumors) harboring activating mutations in CKIT or PDGFRA, who have no effective standard therapy options. Patients receive avapritinib, an oral tyrosine kinase inhibitor selective for CKIT and PDGFRA mutations.

ClinicalTrials.gov ID: NCT04771520

RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I/II Study of AMG757 / Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3

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 relapsed/refractory DLL3-expressing or DLL3-prevalent tumors (including SCLC, LCNEC, high-grade neuroendocrine tumors, and select NSCLC/other histologies) receive the DLL3-directed bispecific T‑cell engager tarlatamab plus external-beam radiation, given concurrently or sequentially depending on safety. Key risks include CRS/ICANS; includes extracranial and cranial RT cohorts with allowance for treated/stable brain mets and selected brain lesions.

ClinicalTrials.gov ID: NCT06814496

Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases

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.

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 melanoma and at least one measurable, untreated brain metastasis (0.5–3 cm), ECOG 0–1, and no steroid-requiring neurologic symptoms receive fixed-dose nivolumab (PD-1 inhibitor) plus relatlimab (LAG-3 inhibitor) IV every 28 days. Prior limited SRT/excision allowed if non-irradiated measurable disease remains; excludes leptomeningeal disease, lesions >3 cm, prior metastatic PD-1 therapy, and significant autoimmune/infectious comorbidities.

ClinicalTrials.gov ID: NCT05704647