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NCT07281924 | RECRUITING | Metastatic Melanoma

Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis
Sponsor:

University of Wisconsin, Madison

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.

Condition or disease

Metastatic Melanoma

Liver Metastases

Intervention/treatment

Nivolumab and Relatlimab

Melphalan

Phase

PHASE1

PHASE2

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. Secondary Objectives * To evaluate the preliminary systemic efficacy of HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™), as measured by ORR, in both hepatic and non-hepatic target lesions in subjects with metastatic melanoma and LM. * To evaluate the disease control rate (DCR) in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™). * To evaluate the PFS in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™). * To evaluate the overall survival (OS) in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™). * To evaluate the duration of response (DOR) in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™). * To evaluate the tumor reduction at any time during treatment in subjects with metastatic melanoma and LM receiving HEPZATO KIT™ in combination with nivolumab and relatlimab (Opdualag™).

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : TREATMENT
Official 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
Actual Study Start Date : 2026-04
Estimated Primary Completion Date : 2030-12
Estimated Study Completion Date : 2030-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

Location Details

NCT07281924

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Locations

RECRUITING

United States, Wisconsin

UW Hospital and Clinics

Madison, Wisconsin, United States, 53792