HEPZATO KIT with Opdualag for metastatic melanoma that has spread to the liver

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 study combines regional liver-directed therapy using the HEPZATO KIT (melphalan delivery) with systemic immunotherapy nivolumab plus relatlimab (Opdualag) in the first-line metastatic setting for patients with liver metastases from melanoma. Co-primary endpoints are safety/tolerability and preliminary systemic efficacy measured by objective response rate compared to historical cohorts. Key requirements include a liver biopsy confirming melanoma metastasis, measurable disease by RECIST v1.1, and adequate organ function. The trial is conducted at the University of Wisconsin Hospital and Clinics and uses historical controls rather than a randomized comparator.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed metastatic melanoma with liver metastasis (LM). Liver biopsy positive for presence of melanoma metastases is required.
* 0-1 line of prior systemic therapy in the unresectable/metastatic setting - prior adjuvant anti-programmed cell death-1 (anti-PD-1) or BRAF/MEK targeted therapy is considered 1 line of prior systemic therapy if less than 6 months from the last treatment.
* Evaluable/measurable disease according to RECIST v1.1.
* Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration.
* Patients must weigh greater than or equal to 35 kilograms (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).

Exclusion Criteria:

* Prior treatment with HEPZATO KIT™ or nivolumab and relatlimab (Opdualag™)
* Radiotherapy is permitted within 30 days prior to C1D1 as long as radiation is given with palliative intent and towards a non-target lesion.
* History of hypersensitivity or treatment discontinuation due to grade 3+ immune-related adverse events (irAEs) from prior anti-PD-(L)1 therapy. Patients who are able to successfully resume immune checkpoint therapy without recurrence of grade 3 irAEs are eligible to participate.
* Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation.
* Prednisone use greater than or equal to 10 mg/d or equivalent
* Organ transplant recipients

Where it's running

• UW Hospital and Clinics
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Vincent Ma, MD — UW Carbone Cancer Center
• Study coordinator: Cancer Connect
• Email: clinicaltrials@cancer.wisc.edu
• Phone: 800-622-8922

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.