HEPZATO KIT with Opdualag for metastatic melanoma that has spread to the liver
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
This will try adding HEPZATO KIT to Opdualag (nivolumab + relatlimab) to see if it's safe and helps people with metastatic melanoma that has spread to the liver.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | nivolumab, relatlimab, radiation, Prednisone |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT07281924 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with biopsy-confirmed metastatic melanoma involving the liver who are treatment-naïve in the unresectable/metastatic setting (prior adjuvant therapy allowed >6 months), have measurable disease, adequate organ function, and weigh ≥35 kg are the intended participants.
Not a fit: Patients previously treated with HEPZATO KIT or with prior nivolumab plus relatlimab, those without liver-biopsy–proven metastases, or those who cannot undergo hepatic catheterization or have inadequate organ function are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could increase response rates and better control liver metastases compared with checkpoint inhibitor therapy alone.
How similar studies have performed: Dual checkpoint blockade with nivolumab plus relatlimab has shown benefit in melanoma and liver-directed melphalan perfusion approaches have produced local control in liver metastases, but combining HEPZATO KIT with Opdualag is a novel approach that has not yet been proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed metastatic melanoma with liver metastasis (LM). Liver biopsy positive for presence of melanoma metastases is required. * Systemic treatment naïve in the unresectable/metastatic setting - prior adjuvant anti-programmed cell death-1 (anti-PD-1) and BRAF/MEK targeted therapy is allowed but must be greater 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 this trial is running
Madison, Wisconsin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.