RecruitingPhase 1Phase 2NCT07281924

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

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


Sponsor

University of Wisconsin, Madison

Enrollment

15 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) in the first line setting in patients with metastatic melanoma with liver metastasis is safe, tolerable, and will have a synergistic effect leading to improved clinical outcomes compared to the historic cohort of patients with liver metastasis treated with combination immune checkpoint inhibitor therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two treatments for metastatic melanoma (skin cancer that has spread to the liver): a liver-directed chemotherapy delivery system called Hepzato Kit, combined with two immunotherapy drugs (nivolumab and relatlimab, sold together as Opdualag). **You may be eligible if...** - You have been confirmed by biopsy to have metastatic melanoma with tumors in the liver - You have not previously received systemic (whole-body) treatment for unresectable or metastatic disease (prior adjuvant therapy is allowed if it ended more than 6 months ago) - Your tumors are measurable on imaging scans - Your organ function is adequate (based on lab tests done within 28 days) - You weigh at least 35 kg **You may NOT be eligible if...** - Your cancer has not been confirmed to involve the liver - You received systemic treatment for metastatic disease less than 6 months ago - You do not meet organ function or performance status requirements - You are too small or otherwise unsuitable for the catheter-based liver procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab and Relatlimab

Relatlimab is a human IgG4 LAG-3 blocking antibody. Nivolumab is a human IgG4 PD-1 blocking antibody. Nivolumab 480 mg and relatlimab 160 mg in a fixed-dose combination will be administered on Day 1 of each 28-day cycle that the participant is on treatment and will be given for up to 2 years from start of treatment.

DEVICEMelphalan

The recommended HEPZATO dose is 3 mg/kg based on ideal body weight (IBW), infusion every 6 to 8 weeks for up to 2 total infusions


Locations(1)

UW Hospital and Clinics

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07281924


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