A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer (RELATIVITY-106)
Trial 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).
Receptor status / problem studied:
Advanced/metastatic hepatocellular carcinoma (HCC)
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
Open for recruitment
Trial Title
Relativity-106
Diagnosis
Liver cancer
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
I/II
Locations
Investigators
Principal Investigator