Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must have a diagnosis of HCC based on histological confirmation - Participants must have an advanced HCC - Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion - 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 - Prior liver transplant - Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization - Active brain metastases or leptomeningeal metastases Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Nivolumab + Ipilimumab
  • Drug: Nivolumab
    Participants will receive nivolumab as intravenous (IV) infusion.
  • Drug: Ipilimumab
    Participants will receive ipilimumab as IV infusion.
Active Comparator
Sorafenib/lenvatinib
  • Drug: Sorafenib
    Participants will receive sorafenib as oral tablets.
  • Drug: lenvatinib
    Participants will receive lenvatinib as oral capsules.

More Details

Status
Active, not recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.