Clinical Trials for Melanoma

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 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

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 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.

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

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 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

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 (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

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