A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Description
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 response after local ablation, and who are at high risk of recurrence
Phase
N/AInclusion and Exclusion 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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