A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT03383458
This clinical trial evaluates nivolumab's efficacy in improving recurrence-free survival in HCC patients post-curative resection or ablation. Eligible participants include those with non-viral, HBV, or HCV-related HCC, Child-Pugh Score 5 or 6, and ECOG PS 0 or 1. Interventions involve administering nivolumab or placebo at specified doses on designated days.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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
Eligibility Criteria
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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0081 | 36207 | Anniston | Alabama |
| Mayo Clinic in Arizona - Phoenix | 85054 | Phoenix | Arizona |
| Arizona Oncology Associates, PC - HOPE | 85711 | Tucson | Arizona |
| Local Institution - 0135 | 90095 | Los Angeles | California |
| Local Institution - 0088 | 94304 | Palo Alto | California |
| Local Institution - 0085 | 94115 | San Francisco | California |
| Local Institution - 0235 | 80045 | Aurora | Colorado |
| Local Institution - 0267 | 33125 | Miami | Florida |
| Sylvester Comprehensive Cancer Center/ UMHC | 33136 | Miami | Florida |
| Local Institution - 0163 | 33612 | Tampa | Florida |
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