Status:
ACTIVE_NOT_RECRUITING
A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 advanc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2025
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT05337137
Start Date
May 5 2022
End Date
November 7 2025
Last Update
August 3 2025
Active Locations (61)
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1
Local Institution - 0042
Los Angeles, California, United States, 90033
2
Local Institution - 0039
Los Angeles, California, United States, 90095
3
Local Institution - 0034
San Francisco, California, United States, 94115
4
Local Institution - 0030
Washington D.C., District of Columbia, United States, 20007