Recruiting
Phase 1
Phase 2

HEPZATO KIT™ & Opdualag™

Sponsor:

University of Wisconsin, Madison

Code:

NCT07281924

Conditions

Metastatic Melanoma

Liver Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nivolumab and Relatlimab

Melphalan

Study Details

Brief summary:

This study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) 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.

Conditions

Metastatic Melanoma

Liver Metastases

Study ID

NCT07281924

Start date

Sep, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with Metastatic Melanoma

Interventions

Nivolumab 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.

Melphalan

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

Primary outcome measure

  • Incidence and Severity of Dose Limiting Toxicities (DLTs) [ Time Frame: up to 12 weeks ]
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: up to 2 years ]
  • Incidence of Serious Treatment-Emergent Adverse Events [ Time Frame: up to 2 years ]
  • Number of Participants that Discontinue Treatment due to Adverse Events [ Time Frame: up to 2 years ]
  • Overall Response Rate (ORR) [ Time Frame: After treatment plus follow up for 2 years (up to 4 years) ]

Central Contacts and Locations

Central contacts

Cancer Connect

800-622-8922clinicaltrials@cancer.wisc.edu

Locations

UW Hospital and Clinics

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Sep 1, 2026

Last verified

Jul, 2026

Keywords

  • immunotherapy
  • Liver metastases
  • Anti-PD-1
  • Anti-LAG-3
  • Melphalan
  • Percutaneous Hepatic Perfusion Therapy
  • Liver directed therapy
  • Nivolumab
  • Relatlimab
  • Immune Checkpoint Inhibitors
  • Hepzato
  • Opdualag

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-09-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.