Clinical Trials for Melanoma

A Phase 1b/2 Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of Melphalan Percutaneous Hepatic Perfusion Therapy (HEPZATO KIT™) With Nivolumab and Relatlimab (Opdualag) in Patients With Metastatic Melanoma and Liver Metastasis

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 unresectable/metastatic melanoma with biopsy-confirmed liver metastasis who are systemic-treatment naïve in the metastatic setting (prior adjuvant anti–PD-1 and/or BRAF/MEK allowed if >6 months), this study combines liver-directed melphalan percutaneous hepatic perfusion via the HEPZATO KIT (temporary hepatic vascular isolation with extracorporeal filtration to limit systemic exposure) with fixed-dose Opdualag (nivolumab PD-1 blockade plus relatlimab LAG-3 blockade to enhance T-cell activation). It evaluates safety and preliminary systemic and hepatic antitumor activity.

ClinicalTrials.gov ID: NCT07281924

A Feasibility Study Utilizing IL-17 Blockade to Decrease Risk of Immune Related Adverse Events

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 metastatic non-uveal melanoma restarting anti–PD-1 therapy alone or with anti–LAG-3 or anti–CTLA-4 after prior grade ≥2 immune-related colitis, hepatitis, or rash receive prophylactic secukinumab, an anti–IL-17A monoclonal antibody, to reduce recurrent immune-related toxicity.

ClinicalTrials.gov ID: NCT07237594

Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY)

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 untreated, unresectable stage III or stage IV melanoma and ECOG performance status 0–1 receive first-line nivolumab (anti–PD-1), relatlimab (anti–LAG-3), and ipilimumab (anti–CTLA-4). The study determines the ipilimumab dose for the triplet and assesses its preliminary activity and tolerability.

ClinicalTrials.gov ID: NCT06683755

A Phase I/II Study of Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab in Advanced Solid Tumors (PNeoVCA)

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: This trial involves adults with unresectable or metastatic advanced solid tumors who have progressed on prior treatments or are candidates for pembrolizumab, combining pembrolizumab, which targets the PD-1 receptor to enhance immune response, with a personalized neoantigen peptide vaccine designed to stimulate an individualized immune attack against tumor-associated proteins.

ClinicalTrials.gov ID: NCT05269381

A Phase 1b/2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination with Ipilimumab Followed by Nivolumab Monotherapy in Patients with Locally Advanced or Metastatic Cancers Following One or More Prior Therapies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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, locally advanced or metastatic solid tumors after at least one prior therapy are eligible for the currently enrolling dose-escalation cohorts, including patients previously treated with anti–PD-1/PD-L1 therapy. Treatment is oral alintegimod, an investigational LFA-1/VLA-4 integrin agonist, initially alone and then with ipilimumab, followed by nivolumab monotherapy.

ClinicalTrials.gov ID: NCT06362369

A Phase 1, First-in-Human, Open-Label, Multi-Center, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LB-LR1109 for the Treatment of Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 or metastatic NSCLC, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or melanoma who lack a suitable standard treatment option receive escalating doses of LB-LR1109 monotherapy. This investigational antibody blocks the inhibitory immune receptor LILRB1 to enhance antitumor immune activity.

ClinicalTrials.gov ID: NCT06332755

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer, PD1/PD-L1 Inhibitor-Refractory Melanoma, and Pretreated Non-Small Cell Lung Cancer

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: This trial evaluates a personalized multi-peptide neo-antigen vaccine combined with poly ICLC and the PD-1 inhibitor nivolumab in adult patients with advanced, treatment-resistant stage IIIC-IV melanoma, hormone receptor positive HER2-negative metastatic breast cancer, and stage III-IV non-small cell lung cancer, focusing on safety and immune response.

ClinicalTrials.gov ID: NCT05098210

A Phase 1/1b Study of VET3-TGI Administered Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 unresectable or metastatic solid tumors and no suitable curative treatment receive intratumoral or intravenous VET3-TGI, alone or with pembrolizumab. VET3-TGI is an oncolytic vaccinia virus engineered to express CXCR3 and IL-12 and inhibit TGF-β to promote tumor killing and antitumor immunity.

ClinicalTrials.gov ID: NCT06444815

Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Melanoma and Lung Cancer Patients With Leptomeningeal Disease (LMD)

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: This trial enrolls adults with leptomeningeal disease from melanoma (all subtypes, including primary CNS) or non-small cell lung cancer, allowing prior therapies, who receive escalating intrathecal nivolumab (anti-PD-1 immune checkpoint inhibitor) combined with standard intravenous nivolumab. The study tests concurrent intrathecal and intravenous administration to increase CNS drug levels for this population.

ClinicalTrials.gov ID: NCT03025256

A First-in-Human, Open-label, Phase 1/2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ENV-501 in Patients With Advanced-Stage, Relapsed/Refractory HER3-Expressing Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Patients with advanced or metastatic HER3-positive solid tumors, including cutaneous melanoma, EGFR-mutated non–small cell lung cancer, and HR-positive/HER2-negative breast cancer, may be eligible if they are relapsed or refractory to standard therapy or have no suitable standard option. Treatment is intravenous ENV-501 every 3 weeks, an investigational HER3-targeted antibody–drug conjugate carrying the topoisomerase I inhibitor exatecan.

ClinicalTrials.gov ID: NCT06956690