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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator
Robin Kate Kelley

Description

Summary

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.

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)

Keywords

Hepatocellular Carcinoma Sorafenib Nivolumab Niacinamide Antibodies, Monoclonal

Eligibility

For people ages 18 years and up

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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

Locations

  • 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
ID
NCT02576509
Phase
Phase 3
Lead Scientist
Robin Kate Kelley
Study Type
Interventional
Last Updated
May 1, 2017