Study on Hepzato Kit and Opdualag for Treating Metastatic Melanoma with Liver Metastasis

Sponsor: University of Wisconsin, Madison

Sponsor score: 0

ClinicalTrials ID:NCT07281924

Provider View

This clinical trial is testing a new combination treatment using Hepzato Kit with Opdualag (nivolumab and relatlimab) to see if it is safe and effective for patients with metastatic melanoma that has spread to the liver.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining Hepzato Kit with the drugs nivolumab and relatlimab (known as Opdualag) is safe and can improve treatment outcomes for patients with metastatic melanoma that has spread to the liver. Researchers hope this combination will work better than previous treatments for similar patients.

Description

The main goals of this study are to check if the combination of Hepzato Kit with Opdualag is safe and can help shrink tumors in patients with metastatic melanoma that has spread to the liver. Researchers will look at how well the treatment works by measuring the response rate, which shows how much the cancer shrinks. They will also evaluate how long patients live without the cancer getting worse, overall survival rates, and how long the treatment effects last. Additionally, the study will assess how much the tumors reduce in size during the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of metastatic melanoma that has spread to the liver, with a positive liver biopsy.
  • Have not received systemic treatment for unresectable or metastatic cancer, although previous treatments like anti-PD-1 or BRAF/MEK targeted therapy are allowed if they were completed more than 6 months ago.
  • Have measurable cancer according to standard criteria.
  • Have adequate organ function based on recent lab tests.
  • Weigh at least 35 kilograms to ensure safe use of the treatment delivery system.

Exclusion Criteria

  • Have previously been treated with Hepzato Kit or Opdualag (nivolumab and relatlimab).
  • Have received radiotherapy within 30 days before starting the study, unless it was for symptom relief and not targeting the main cancer areas.
  • Have a history of severe allergic reactions or had to stop previous immune therapy due to serious side effects, unless they were able to restart without issues.
  • Have uncontrolled or symptomatic brain metastases, or spinal cord issues not treated with surgery or radiation.
  • Are taking prednisone at a dose of 10 mg or more per day.
  • Have received an organ transplant.

Locations

FACILITYZIPCITYSTATE
UW Hospital and Clinics53792MadisonWisconsin

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