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

Running, not enrolling · Phase 3

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT04039607

Run by

Bristol-Myers Squibb

People needed

732

Starts

2019-09-30

Expected to finish

2026-07-09

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0288 — Coronado, California, United States
• Local Institution - 0157 — Duarte, California, United States
• Local Institution - 0077 — Washington D.C., District of Columbia, United States
• Local Institution - 0027 — Louisville, Kentucky, United States
• Local Institution - 0190 — Baltimore, Maryland, United States
• Local Institution — Ann Arbor, Michigan, United States
• Local Institution - 0018 — Detroit, Michigan, United States
• Local Institution - 0295 — Newark, New Jersey, United States
• Local Institution - 0043 — Toledo, Ohio, United States
• Local Institution - 0284 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0304 — Dallas, Texas, United States
• Local Institution - 0202 — Houston, Texas, United States
• Local Institution - 0046 — Lubbock, Texas, United States
• Local Institution - 0172 — Salt Lake City, Utah, United States
• Local Institution - 0037 — Caba, Buenos Aires, Argentina
• Local Institution - 0194 — Pilar, Buenos Aires, Argentina
• Local Institution - 0282 — Rosario, Santa Fe Province, Argentina
• Local Institution - 0136 — Buenos Aires, Argentina
• Local Institution - 0058 — San Miguel de Tucumán, Argentina
• Local Institution - 0003 — Kogarah, New South Wales, Australia
• Local Institution - 0038 — Liverpool, New South Wales, Australia
• Local Institution - 0002 — Westmead, New South Wales, Australia
• Local Institution - 0004 — Birtinya, Queensland, Australia
• Local Institution - 0013 — Herston, Queensland, Australia
• Local Institution - 0292 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.