A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma
Description
Brief Summary
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).
Phase
N/AInclusion and Exclusion 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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