Actively Recruiting
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Led by University of Wisconsin, Madison · Updated on 2026-05-05
15
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
D
Delcath Systems Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic melanoma with liver metastasis; liver biopsy positive for melanoma metastases required
- No prior systemic treatment in unresectable/metastatic setting within last 6 months; prior adjuvant anti-PD-1 and BRAF/MEK therapy allowed if over 6 months ago
- Measurable disease according to RECIST v1.1
- Adequate organ function as shown by screening labs within 28 days before registration
- Patient weight of at least 35 kilograms due to catheterization size requirements
You will not qualify if you...
- Prior treatment with HEPZATO KIT17 or nivolumab and relatlimab (Opdualag17)
- Radiotherapy within 30 days before first treatment cycle unless palliative and not targeting study lesions
- History of grade 3 or higher immune-related adverse events from prior anti-PD-(L)1 therapy leading to treatment stop, unless immune checkpoint therapy was successfully resumed without recurrence
- Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated
- Use of prednisone 10 mg/day or higher or equivalent
- Organ transplant recipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UW Hospital and Clinics
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
C
Cancer Connect
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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