An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma

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About the study

The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.
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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

Inclusion Criteria:


  1. Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
  2. Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan
  3. Child-Pugh Class A
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  2. Prior liver transplant
  3. Active, known, or suspected autoimmune disease

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.

Study Details


Contition
Hepatocellular Carcinoma
Age (in years)
18+
Phase
PHASE3
Participants Needed
743
Est. Completion Date
Feb 7, 2024
Treatment Type
INTERVENTIONAL

Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov NCT Identifier
NCT02576509
Study Number
CA209459

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