Clinical Trials for Melanoma

Phase 2 Sequential Treatment With Melphalan/HDS Via Percutaneous Hepatic Perfusion Followed by Tebentafusp in the Treatment of Metastatic Uveal Melanoma

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: Eligible patients are adults with ECOG 0–1, HLA-A*02:01–positive metastatic uveal melanoma with liver-dominant disease (≤50% liver replacement) and at least one measurable hepatic lesion, with significant extrahepatic disease largely excluded. Treatment is two sequential percutaneous hepatic perfusions delivering high-dose melphalan with extracorporeal hemofiltration 6–8 weeks apart, followed by up to 1 year of weekly tebentafusp (a gp100 peptide–HLA-directed TCR/anti-CD3 bispecific that redirects T cells to gp100-expressing melanoma cells), with additional PHP allowed on progression as standard of care.

ClinicalTrials.gov ID: NCT07276386

Phase I/II Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (TIL) for Patients With Advanced Melanoma

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 or metastatic melanoma (cutaneous/acral; plus a cohort for mucosal or uveal), ECOG 0–1, progressed after at least one standard systemic therapy (e.g., anti–PD-1/L1; BRAF±MEK if BRAF V600-mutant), with an accessible lesion for harvest and stable treated brain metastases allowed. Patients undergo tumor resection for manufacturing, lymphodepleting cyclophosphamide/fludarabine, then a single infusion of autologous CD40L-augmented tumor-infiltrating lymphocytes (CD40 ligand signaling to enhance APC activation/costimulation) followed by short-course bolus aldesleukin (IL-2) support.

ClinicalTrials.gov ID: NCT06961357

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

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

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: 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: This trial involves patients with advanced or metastatic solid tumors, such as melanoma and non-small cell lung cancer, who have had prior therapies, evaluating the safety and efficacy of Alintegimod, an integrin-targeting agent, combined with ipilimumab and nivolumab.

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: The trial is for adult patients with advanced or metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, or malignant melanoma who have no remaining standard treatment options, and it evaluates the safety, tolerability, and dosing of the investigational drug LB-LR1109, administered intravenously.

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

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: 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 First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants 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: This trial enrolls adults with unresectable, locally advanced or metastatic solid tumors—including a wide range such as head and neck, lung, bladder, prostate, breast, colorectal, and others—who have progressed on or are intolerant to standard therapies. Patients receive MGC026, a B7-H3-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor (exatecan), with cohorts in both dose escalation and expansion phases.

ClinicalTrials.gov ID: NCT06242470

A Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 Delivered by Intratumoral Injection in Patients With Advanced Solid Tumors as a Monotherapy or in Combination With Pembrolizumab

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: Eligible adult patients with advanced or metastatic solid tumors (including dedicated cohorts for TNBC and melanoma) whose disease is refractory or progressed after standard therapy may receive intratumoral STX-001, a self-replicating mRNA encoding IL-12, as monotherapy or combined with pembrolizumab. Enrollment requires an accessible lesion for injection/biopsy and ECOG 0-1.

ClinicalTrials.gov ID: NCT06249048