A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
Phase 3 – large-scale trial before approval
Conditions:
Hepatocellular Carcinoma
Sponsor: Bristol-Myers Squibb
trial.available_in:
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Overview
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 hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Who can participate
Inclusion Criteria:
* 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 Criteria:
* 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.
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