A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Official record

Identifier

NCT03383458

Recruiting locations

countries

United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChileColombiaFranceGermanyHong KongItalyJapanMexicoNetherlandsNew ZealandPuerto RicoRomaniaRussiaSingaporeSouth KoreaSpainTaiwanUnited Kingdom

Interventions studied

NivolumabPlacebo

Lead sponsor

Bristol-Myers Squibb

Target enrolment

545 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Active, not recruiting

First posted

Dec 26, 2017

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
* Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
* 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
* Any evidence of tumor metastasis or co-existing malignant disease
* Participants previously receiving any prior therapy for HCC, including loco-regional therapies
* Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
* Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella \[MMR\]).

Other protocol defined inclusion/exclusion criteria apply

Indexed under

Liver Cancer