Status:
ACTIVE_NOT_RECRUITING
A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Ono Pharmaceutical Co. Ltd
Conditions:
Hepatocellular Carcinoma
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 resp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2031
Estimated Enrollment :
545 Patients enrolled
Trial Details
Trial ID
NCT03383458
Start Date
April 18 2018
End Date
February 27 2031
Last Update
November 21 2025
Active Locations (184)
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1
Local Institution - 0081
Anniston, Alabama, United States, 36207
2
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States, 85054
3
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States, 85711
4
Local Institution - 0135
Los Angeles, California, United States, 90095