Overview

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

Status:
Active, not recruiting
Trial end date:
2025-01-04
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Ipilimumab
Lenvatinib
Nivolumab
Sorafenib
Criteria
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 inclusion/exclusion criteria may apply.