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Clinical Trial NCT07281924 for Metastatic Melanoma, Liver Metastases is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of Wisconsin, MadisonHepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis Phase 1, Phase 2 15
Clinical Trial NCT07281924 is designed to study Treatment for Metastatic Melanoma, Liver Metastases. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 1 April 2026, with plans to enroll 15 participants. Led by University of Wisconsin, Madison, it is expected to complete by 1 December 2030. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
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.
Detailed Description
Co-Primary Objectives
- To evaluate the safety and tolerability of HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™) in subjects with metastatic melanoma and liver metastasis (LM).
- To evaluate the preliminary systemic efficacy of HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™), as measured by objective response rate (ORR), in subjects with metastatic melanoma and LM.
Seco...
Show MoreOfficial Title
A Phase 1b/2 Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of Melphalan Percutaneous Hepatic Perfusion Therapy (HEPZATO KIT™) With Nivolumab and Relatlimab (Opdualag) in Patients With Metastatic Melanoma and Liver Metastasis
Conditions
Metastatic MelanomaLiver MetastasesOther Study IDs
- 2025-1424
- UW25072 (Other Identifier) (OnCore ID)
- Protocol Version 9/26/25 (Other Identifier) (UW Madison)
- SMPH/MEDICINE/HEM-ONC (Other Identifier) (UW Madison)
NCT ID Number
Start Date (Actual)
2026-04
Last Update Posted
2026-03-24
Completion Date (Estimated)
2030-12
Enrollment (Estimated)
15
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Keywords
immunotherapy
Liver metastases
Anti-PD-1
Anti-LAG-3
Melphalan
Percutaneous Hepatic Perfusion Therapy
Liver directed therapy
Nivolumab
Relatlimab
Immune Checkpoint Inhibitors
Hepzato
Opdualag
Liver metastases
Anti-PD-1
Anti-LAG-3
Melphalan
Percutaneous Hepatic Perfusion Therapy
Liver directed therapy
Nivolumab
Relatlimab
Immune Checkpoint Inhibitors
Hepzato
Opdualag
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalParticipants with Metastatic Melanoma | Nivolumab and Relatlimab 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 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | up to 12 weeks |
Incidence of Treatment-Emergent Adverse Events | up to 2 years | |
Incidence of Serious Treatment-Emergent Adverse Events | up to 2 years | |
Number of Participants that Discontinue Treatment due to Adverse Events | 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). | After treatment plus follow up for 2 years (up to 4 years) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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). | 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. | 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. | 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). | After treatment plus follow up for 2 years (up to 4 years) |
Number of Participants with Tumor Reduction at any time | After treatment plus follow up for 2 years (up to 4 years) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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).
- 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
University of Wisconsin, Madison243 active studies to exploreDelcath Systems Inc.4 active studies to exploreStudy Central Contact
Contact: Cancer Connect, 800-622-8922, [email protected]
1 Study Locations in 1 Countries
Wisconsin
UW Hospital and Clinics, Madison, Wisconsin, 53792, United States
Recruiting