Clinical Trials for Melanoma

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 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.

TrialFetch 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.

TrialFetch 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

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

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.

TrialFetch AI summary: Adults with advanced solid tumors (safety cohort) or anti–PD-(L)1–refractory melanoma enriched for acral subtype (efficacy cohort), ECOG 0–1, with 1–4 lesions suitable for SBRT. Treatment is concurrent SBRT plus nivolumab and BMS-986253 (anti–IL-8 monoclonal antibody that neutralizes CXCL8 to reduce neutrophil/MDSC trafficking and enhance antitumor immunity).

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

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)

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 locally advanced or metastatic solid tumors eligible for on-label PD-1 therapy (nivolumab or pembrolizumab) are randomized in a crossover design to receive standard PD-1 inhibitors via subcutaneous versus intravenous administration, assessing patient/clinician preference, satisfaction, QoL, safety, and selected clinical outcomes. Includes PD-(L)1–naïve patients or those willing to switch; excludes prior severe hypersensitivity and transplant history.

ClinicalTrials.gov ID: NCT07223424

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

Knight Cancer Institute Study of Histology-Agnostic Immunotherapy With Focus on Timing: - Knight SHIFT - A Prospective, Multi-Histology Pragmatic Study

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 measurable advanced/metastatic solid tumors eligible for standard FDA-approved immune checkpoint inhibitor therapy (anti–PD-1/PD-L1 and/or anti–CTLA-4), including NSCLC, HNSCC, RCC, biliary, HCC, and melanoma, who are ICI-naive. Patients are randomized to receive their planned standard-of-care immunotherapy in the morning versus afternoon for the first 4 doses to evaluate whether administration timing affects outcomes.

ClinicalTrials.gov ID: NCT07405086