Status:
ACTIVE_NOT_RECRUITING
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced...
Eligibility Criteria
Inclusion
- Participants must have a diagnosis of HCC based on histological confirmation
- Participants must have an advanced HCC
- Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
- Child-Pugh score 5 or 6
- Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1
Exclusion
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Prior liver transplant
- Episodes of hepatic encephalopathy (greater than or equal to \[\>=\] Grade 2) within 12 months prior to randomization
- Active brain metastases or leptomeningeal metastases
- Other protocol-defined inclusion/exclusion criteria apply.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2026
Estimated Enrollment :
732 Patients enrolled
Trial Details
Trial ID
NCT04039607
Start Date
September 30 2019
End Date
September 30 2026
Last Update
August 3 2025
Active Locations (210)
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1
Local Institution - 0292
Tucson, Arizona, United States, 85719
2
Local Institution - 0288
Coronado, California, United States, 92118
3
Local Institution - 0157
Duarte, California, United States, 91010-3012
4
Local Institution - 0077
Washington D.C., District of Columbia, United States, 20007