A Phase 3 Study of Nivolumab versus Placebo for Participants with Hepatocellular Cancer Who Are at High Risk of Recurrence after Hepatic Resection or Ablatio
- Conditions
- Hepatocellular CarcinomaMedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-508726-10-00
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 796
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.
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC., Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured., 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., Positive pregnancy test., Prior recurrence of HCC., Any evidence of tumor metastasis or co-existing malignant disease., Participants showing evidence of macrovascular invasion on imaging tests., Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation., 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., Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare recurrence-free survival (RFS) (based on BICR assessment) of nivolumab vs placebo in all randomized participants.;Secondary Objective: To compare overall survival (OS) of nivolumab vs placebo in all randomized participants., To evaluate time to recurrence (TTR) (based on BICR assessment) of nivolumab vs placebo in all randomized participants.;Primary end point(s): Recurrence free survival (RFS), defined as the time from randomization to the first documented disease recurrence or death (by any cause), whichever occurs first.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):OS, defined as the time between the date of randomization and the date of death (by any cause).;Secondary end point(s):Time to Recurrence (TTR), defined as the time from randomization to the first documented disease recurrence.