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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA224-106  |   NCT05337137

A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer

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Sorry, this study is no longer accepting new participants, but is still ongoing.
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Summary

  • Phase 1/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 safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC)
    1. Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team)
      1. Child-Pugh score of 5 or 6 (ie, Child-Pugh A)
        1. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
            1. Prior allogenic stem cell or solid organ transplantation
              1. Untreated symptomatic central nervous system (CNS) metastases
                1. Clinically significant ascites as defined by:
                  1. Prior ascites that required treatment and requires on-going prophylaxis, or
                    1. Current ascites requiring treatment Other protocol-defined inclusion/exclusion criteria apply
                    Additional Information *

                    Treatment Options

                    Study Arms

                    ASSIGNED INTERVENTION

                    Study Arms

                    Experimental: Arm A: Relatlimab + Nivolumab + Bevacizumab

                    ASSIGNED INTERVENTION
                    • Drug: Relatlimab, Nivolumab, Bevacizumab

                    Study Arms

                    Experimental: Arm B: Placebo + Nivolumab + Bevacizumab

                    ASSIGNED INTERVENTION
                    • Drug: Nivolumab, Bevacizumab
                    • Other: Placebo

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