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

NCT04039607 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 732

Last updated 2026-04-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2026-07-09
Completion
2026-07-09
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04039607 on ClinicalTrials.gov