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

  • Interventional
  • Active
  • NCT02576509
Eligibility Details Visit

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)

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


Age Group
18 Years and up

Accepting Healthy Volunteers?

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

        Other protocol-defined inclusion/exclusion criteria apply

At a Glance

National Government IDNCT02576509


Lead SponsorBristol-Myers Squibb

Lead PhysicianChih-Yi Liao


18 Years and up