NCT03383458

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 545 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatocellular Carcinoma
• Liver Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Specified dose on specified days
OTHER	Placebo	specified dose on specified days

Timeline

• Start date: 2018-04-18
• Primary completion: 2026-02-27
• Completion: 2031-02-27
• First posted: 2017-12-26
• Last updated: 2025-11-21

Locations

184 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, France, Germany, Hong Kong, Italy, Japan, Mexico, Netherlands, New Zealand, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study