For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Participants must have a diagnosis of HCC based on histological confirmation
  2. Participants must have an advanced HCC
  3. Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
  4. Child-Pugh score 5 or 6
  5. Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1

EXCLUSION CRITERIA

  1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  2. Prior liver transplant
  3. Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
  4. Active brain metastases or leptomeningeal metastases Other protocol-defined inclusion/exclusion criteria apply.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
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Study’s details


Contition

Hepatocellular Carcinoma

Age

18+

Phase

Phase 3

Participants needed

732

Est. Completion Date

Jun 2025

Treatment type

Interventional


Sponsor

Bristol-Myers Squibb

ClinicalTrials.gov identifier

NCT04039607

Study number

CA209-9DW

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