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Active Not Recruiting
NCT03383458
A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Conditions: Hepatocellular Carcinoma, Liver Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 545
Sponsor: Bristol-Myers Squibb
Location: Local Institution - 0081 Anniston Alabama
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 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
Source: ClinicalTrials.gov (NCT03383458). StuddyBuddy aggregates publicly available trial information.