Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis

Sponsor: University of Wisconsin, Madison

Sponsor score: 0

ClinicalTrials ID:NCT07281924

This study evaluates the safety and efficacy of HEPZATO KIT™ with nivolumab and relatlimab in metastatic melanoma with liver metastasis. Eligible patients must have confirmed liver metastasis, be treatment-naïve in the metastatic setting, and meet specific health criteria. Interventions include nivolumab/relatlimab and melphalan, administered in defined cycles.

Patient Parameters

Program Overview

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.

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™).

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

Locations

FACILITYZIPCITYSTATE
UW Hospital and Clinics53792MadisonWisconsin

Get This Program In Your Inbox

You can sign up and apply your patients for this program.