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Trial ID CA224-073  |   NCT04567615

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

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to evaluate the effectiveness and safety 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 inhibitor therapy.

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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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Arm A : Nivolumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab

Study Arms

Experimental: Arm B : Nivolumab + Relatlimab Dose 1

ASSIGNED INTERVENTION
  • Biological: Nivolumab, Relatlimab

Study Arms

Experimental: Arm C : Nivolumab + Relatlimab Dose 2

ASSIGNED INTERVENTION
  • Biological: Nivolumab, Relatlimab

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