A Phase 1/2 interventional study of Nivolumab and Relatlimab and Melphalan in Metastatic Melanoma and Liver Metastases, sponsored by University of Wisconsin, Madison. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University of Wisconsin, Madison · Phase 1/2, Interventional, and Treatment
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.
Co-Primary Objectives
Secondary Objectives
Exclusion Criteria:
Drug: Nivolumab and Relatlimab · Device: Melphalan
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.
Also known as: Opdualag
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
Also known as: HEPZATO KIT
Incidence and Severity of Dose Limiting Toxicities (DLTs)
A DLT is defined as any grade 4+ non-hematologic event lasting greater than 3 days (despite appropriate medical management) considered possibly related to study treatment (HEPZATO KIT™ or Opdualag™) within 12 weeks of Cycle 1 Day 1.
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)
The objective response rate is the proportion of all participants with confirmed Partial Response (PR) or Complete Response (CR) according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment).
Time frame: After treatment plus follow up for 2 years (up to 4 years)
ORR in Hepatic and Non-Hepatic Lesions
The proportion of all participants with confirmed PR or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment) in Hepatic and Non-Hepatic Target Lesions.
Time frame: After treatment plus follow up for 2 years (up to 4 years)
Disease Control Rate (DCR)
The disease control rate is the proportion of all subjects with SD for 8 weeks, or PR, or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment).
Time frame: After treatment plus follow up for 2 years (up to 4 years)
Progression Free Survival (PFS)
A measurement from the date of randomization until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs. Participants who have not progressed will be right-censored at the date of the last disease evaluation.
Time frame: After treatment plus follow up for 2 years (up to 4 years)
Overall Survival (OS)
Overall survival is defined by the date of randomization to date of death from any cause.
Time frame: After treatment plus follow up for 2 years (up to 4 years)
Duration of Response (DOR)
Duration of overall response-the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started).
Time frame: After treatment plus follow up for 2 years (up to 4 years)
Number of Participants with Tumor Reduction at any time
Time frame: After treatment plus follow up for 2 years (up to 4 years)
Plan to share: Yes — Researchers must have local IRB approval for their study that is to include study of the biospecimens and accompanying data. Release of biospecimens to non-UW researchers will be performed according to all UW regulatory policies. Tissue (including blood) specimen as part of this research will be primarily stored at UW and may be sent to an outside lab/facility to achieve the objectives of the study. No study data or patient health information will be shared with a third party.
Supporting information: Study protocol, Sap, Icf
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University of Wisconsin, Madison