NCT04039607

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 732 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Participants will receive nivolumab as intravenous (IV) infusion.
DRUG	Ipilimumab	Participants will receive ipilimumab as IV infusion.
DRUG	Sorafenib	Participants will receive sorafenib as oral tablets.
DRUG	lenvatinib	Participants will receive lenvatinib as oral capsules.

Timeline

• Start date: 2019-09-30
• Primary completion: 2026-07-09
• Completion: 2026-07-09
• First posted: 2019-07-31
• Last updated: 2026-04-06

Locations

210 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Italy, Japan, New Zealand, Poland, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study