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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

Inclusion Criteria Icon img
:
  • Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation
    1. Must have advanced/metastatic HCC
      1. Have to be immunotherapy treatment-naive in the advanced/metastatic setting
        1. Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion
          1. Child-Pugh score of 5 or 6
            1. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale Key

              Exclusion Criteria

              Exclusion Criteria Icon
              :
              • Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma
                1. Prior organ allograft or allogeneic bone marrow transplantation
                  1. No uncontrolled or significant cardiovascular disease
                    1. No active known autoimmune disease
                      1. Have received one or two lines of tyrosine kinase inhibitor therapies
                        1. Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy Other protocol-defined inclusion/exclusion criteria apply
                          Additional Information *

                          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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