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Active, Not Recruiting

A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors - CA224-073

Updated: 12 March, 2024   |   ClinicalTrials.gov

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Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A : Nivolumab
Biological: Nivolumab
Experimental: Arm B : Nivolumab + Relatlimab Dose 1
Biological: Nivolumab, Relatlimab
Experimental: Arm C : Nivolumab + Relatlimab Dose 2
Biological: Nivolumab, Relatlimab

Key Eligibility Criteria

Key Inclusion Criteria: - Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation - Must have advanced/metastatic HCC - Have to be immunotherapy treatment-naive in the advanced/metastatic setting - Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion - Child-Pugh score of 5 or 6 - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale Key Exclusion Criteria: - Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma - Prior organ allograft or allogeneic bone marrow transplantation - No uncontrolled or significant cardiovascular disease - No active known autoimmune disease - Have received one or two lines of tyrosine kinase inhibitor therapies - Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy Other protocol-defined inclusion/exclusion criteria apply

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