A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Purpose
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
Conditions
- Hepatocellular Carcinoma
- Liver Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A |
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|
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Placebo Comparator Arm B |
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More Details
- Status
- Active, not recruiting
- Sponsor
- Bristol-Myers Squibb