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

Trial details

Who runs it

Bristol-Myers Squibb Services Unlimited Company

Trial code

EU 2023-508726-10-00

Record updated

2026. szeptember 3.

Original description

To compare recurrence-free survival (RFS) (based on BICR assessment) of nivolumab vs placebo in all randomized participants.Read full original descriptionShow less

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 (CheckMate 9DX: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9DX)

To compare recurrence-free survival (RFS) (based on BICR assessment) of nivolumab vs placebo in all randomized participants.

Inclusion: 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.

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

EU CTIS 2023-508726-10-00