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

• Status: Not yet recruiting
• Trial end date: 2025-01-04
• Target enrollment: 0
• Participant gender: All

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: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Bevacizumab; Nivolumab

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