A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (CheckMate 9DX)

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting

Phase 3

Conditions

Hepatocellular Carcinoma

Liver Cancer

Treatments

Biological: Nivolumab

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03383458

CA209-9DX

Details and patient eligibility

About

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

Enrollment

545 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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