A Phase 3 Study of Nivolumab versus Placebo for Participants with Hepatocellular Cancer Who Are at High Risk of Recurrence after Hepatic Resection or Ablation

Prior treatment

• Participants previously receiving any prior therapy for HCC, including loco-regional therapies, before or after resection or ablation.
• Participants receiving or expected to receive IFN-based therapies during the study period.
• Prior recurrence of HCC.
• Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation.
• Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment.

Other illness

• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
• Any evidence of tumor metastasis or co-existing malignant disease.
• Active co-infection with both Hepatitis B and C, OR Hepatitis D and B.
• Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Participants with an active, known or suspected autoimmune disease.

Other

• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
• Positive pregnancy test.
• Participants showing evidence of macrovascular invasion on imaging tests.

• Males and females, ages 18 or older.
• Participants must have a first diagnosis of HCC amenable for management with curative intent by resection or local ablation.
• Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC.
• Participants are eligible to enroll if they have undergone: i) Hepatic resection and have the following tumor characteristics: up to three tumors, at least one with a diameter > 5 cm OR none with a diameter > 5 cm but with confirmation of microvascular invasion or poorly /undifferentiated HCC; or more than three tumors, none with a diameter > 5 cm ii) Local ablation [radiofrequency ablation (RFA) or microwave ablation (MWA)] and have the following tumor characteristics: solitary tumor > 3cm but <=5 cm; OR Multiple tumors (up to 4), none with a diameter > 5 cm
• Participants must have complete resection response, or must have achieved radiologically documented complete resection after local ablation.
• All participants are required to have imaging studies confirming disease-free status at least 4 weeks after either complete tumor removal after surgical resection or local ablation, and within 4 weeks prior to randomization.
• Child-Pugh Score 5 or 6.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.