Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Nivolumab and Relatlimab
- Melphalan
Treatment groups
15 Participants
are divided into 1 treatment groupLocations
1UW Hospital and Clinics53792, MadisonWisconsin, United States
Sponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
Delcath Systems Inc.
Collaborator
Source ClinicalTrials.gov