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for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Robin Kate Kelley



The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma. NOTE: Global recruitment is complete but enrollment is ongoing for the China sub-study. The Completion Date for the Primary Outcome Measure is expected in October 2018.

Official Title

A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)


Hepatocellular Carcinoma Sorafenib Nivolumab Niacinamide Antibodies, Monoclonal


For people ages 18 years and up

For more information regarding BMS clinical trial participation, please visit

NOTE: Global recruitment is complete but enrollment is ongoing for the China sub-study

Inclusion Criteria:

  • Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
  • Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan
  • Child-Pugh Class A
  • 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
  • Active, known, or suspected autoimmune disease


  • Pacific Hematology Oncology Associates in progress, not accepting new patients
    San Francisco, California, 94115, United States
  • Ucla-Division Of Hematology/Oncology in progress, not accepting new patients
    Los Angeles, California, 90095, United States


accepting new patients
Start Date
Completion Date
Bristol-Myers Squibb
BMS Clinical Trial Information
BMS clinical trial educational resource
FDA Safety Alerts and Recalls
Investigator Inquiry Form
Phase 3
Lead Scientist
Robin Kate Kelley
Study Type
Last Updated
September 1, 2017