Summary

for people ages 18 years and up (full criteria)
at Vallejo, California and other locations
study started
estimated completion

Description

Summary

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

Official Title

A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Keywords

Hepatocellular Carcinoma Liver Cancer Carcinoma Carcinoma, Hepatocellular Recurrence Nivolumab

Eligibility

For people ages 18 years and up

For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
  • Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
  • Child-Pugh Score 5 or 6
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Any evidence of tumor metastasis or co-existing malignant disease
  • Participants previously receiving any prior therapy for HCC, including loco-regional therapies
  • Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation

Other protocol defined inclusion/exclusion criteria could apply

Locations

  • Local Institution not yet accepting patients
    Vallejo California 94589-2441 United States
  • California Pacific Medical Center Research Institute accepting new patients
    San Francisco California 94115 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Sign up for this study
ID
NCT03383458
Phase
Phase 3
Study Type
Interventional
Last Updated