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Trial ID CA224-106  |   NCT05337137

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

Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 35
    Locations
  • BMS Recruiting Study icon
    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).

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Key Eligibility Criteria

Inclusion Criteria: - Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC) - 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) - Child-Pugh score of 5 or 6 (ie, Child-Pugh A) - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: - Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC - Prior allogenic stem cell or solid organ transplantation - Untreated symptomatic central nervous system (CNS) metastases - Clinically significant ascites as defined by: i) Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment Other protocol-defined inclusion/exclusion criteria apply

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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