NCT07281924 Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
| NCT ID | NCT07281924 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Wisconsin, Madison |
| Condition | Metastatic Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-07 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2026-07 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Vincent Ma, MD
PRINCIPAL INVESTIGATOR
UW Carbone Cancer Center
Frequently Asked Questions
Who can join the NCT07281924 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07281924 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07281924 currently recruiting?
Yes, NCT07281924 is actively recruiting participants. Contact the research team at clinicaltrials@cancer.wisc.edu for enrollment information.
Where is the NCT07281924 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT07281924 clinical trial?
NCT07281924 is sponsored by University of Wisconsin, Madison. The principal investigator is Vincent Ma, MD at UW Carbone Cancer Center. The trial plans to enroll 15 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.