A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT04039607
This clinical trial evaluates overall survival in advanced hepatocellular carcinoma patients receiving nivolumab and ipilimumab versus standard care (sorafenib or lenvatinib). Eligible participants must have histologically confirmed advanced HCC, a RECIST 1.1 measurable lesion, Child-Pugh score 5 or 6, and ECOG PS 0 or 1. Interventions include IV infusions of nivolumab and ipilimumab, and oral sorafenib or lenvatinib.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Eligibility 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-defined inclusion/exclusion criteria apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0292 | 85719 | Tucson | Arizona |
| Local Institution - 0288 | 92118 | Coronado | California |
| Local Institution - 0157 | 91010-3012 | Duarte | California |
| Local Institution - 0077 | 20007 | Washington D.C. | District of Columbia |
| Local Institution - 0027 | 40217 | Louisville | Kentucky |
| Local Institution - 0190 | 21287 | Baltimore | Maryland |
| Local Institution | 48105 | Ann Arbor | Michigan |
| Local Institution - 0018 | 48202 | Detroit | Michigan |
| Local Institution - 0295 | 07103 | Newark | New Jersey |
| Local Institution - 0043 | 43623 | Toledo | Ohio |
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