This study is in progress, not accepting new patients

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

a study on Hepatocellular Cancer Hepatocellular Carcinoma Liver Cancer Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by 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.

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, Carcinoma, Nivolumab, Sorafenib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Local Institution - 0084
    San Francisco California 94143 United States
  • Local Institution - 0015
    San Francisco California 94115 United States

Lead Scientist at UCSF

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls Investigator Inquiry Form
ID
NCT02576509
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 743 people participating
Last Updated