Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07281924
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab and Relatlimab — DRUG
    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 — DEVICE
    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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with Metastatic Melanoma

Primary Outcome Measure

Incidence and Severity of Dose Limiting Toxicities (DLTs) [ Time Frame: up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UW Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Madison, WI

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
UW Hospital and Clinics· Madison, WI

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