A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    650
  • sponsor
    Bristol-Myers Squibb
Updated on 28 July 2021
systemic therapy
nivolumab
sorafenib
lenvatinib

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 hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Details
Condition Adenocarcinoma, HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA, Liver Cancer, Malignant Adenoma, liver cell carcinoma
Treatment Ipilimumab, Nivolumab, Sorafenib, Lenvatinib
Clinical Study IdentifierNCT04039607
SponsorBristol-Myers Squibb
Last Modified on28 July 2021

Eligibility

Yes No Not Sure

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 inclusion/exclusion criteria may apply
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