A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma (CheckMate 9DW)

  • End date
    Jan 4, 2025
  • participants needed
  • sponsor
    Bristol-Myers Squibb
Updated on 14 October 2022
systemic therapy


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.

Condition Hepatocellular Carcinoma
Treatment Ipilimumab, Nivolumab, Sorafenib, Lenvatinib
Clinical Study IdentifierNCT04039607
SponsorBristol-Myers Squibb
Last Modified on14 October 2022


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-defined inclusion/exclusion criteria apply
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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