Study on the Safety and Effectiveness of Livmoniplimab and Budigalimab for Liver Cancer

Sponsor: AbbVie

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05822752

Provider View

This clinical trial is testing a new combination of drugs, livmoniplimab and budigalimab, to see if they are safe and effective in treating adults with liver cancer that cannot be removed by surgery or has spread to other parts of the body.

Patient Parameters

Program Overview

Liver cancer, specifically hepatocellular carcinoma (HCC), is a common and serious type of cancer. This study aims to find the best dose and check for any side effects of a new drug combination, livmoniplimab and budigalimab, in treating HCC. Participants will be randomly assigned to one of three groups: one group will receive standard treatment with either lenvatinib or sorafenib, while the other two groups will receive different doses of livmoniplimab combined with budigalimab. The study will involve about 120 adults at 60 locations worldwide and will last up to 2 years. Participants will have regular hospital or clinic visits for check-ups, blood tests, and scans.

Eligibility Criteria

Inclusion Criteria

  • Have a Child-Pugh A classification, which indicates good liver function.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have previously received an immune checkpoint inhibitor as part of their first treatment for liver cancer.
  • Have good blood and organ function.
  • Be willing to have a tissue biopsy at the start of the study.
  • Have liver cancer that cannot be treated with surgery or local therapies, or that has worsened after such treatments.

Exclusion Criteria

  • Have untreated or worsening cancer that has spread to the brain or spinal cord.
  • Have previously been treated with certain drugs like sorafenib or lenvatinib for liver cancer.
  • Have had another type of cancer within the last 5 years, except for liver cancer.
  • Have liver-related brain issues or need medication to manage these issues.
  • Have moderate or severe fluid buildup in the abdomen that requires frequent treatment.
  • Have active infections with both hepatitis B and C.
  • Have had severe immune-related side effects from previous treatments.
  • Have had repeated lung inflammation or pneumonia.

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