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 carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-002755-29-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 883
1. Males and females, ages 18 or older.
2. Participants must have a first diagnosis of HCC amenable for management with curative intent by resection or local ablation.
3. Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
4. 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
5. Participants must have complete resection response, or must have achieved radiologically documented complete resection after local ablation.
6. 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.
7. Child-Pugh Score 5 or 6
8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 441
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 442
1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
2. Prior recurrence of HCC.
3. Any evidence of tumor metastasis or co-existing malignant disease.
4. Participants showing evidence of macrovascular invasion on imaging tests.
5. Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation.
6. Active co-infection with with both Hepatitis B and C, OR Hepatitis D and B
7. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
8. Participants with an active, known or suspected autoimmune disease.
9. Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment.
10. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
11. Participants previously receiving any prior therapy for HCC, including loco-regional therapies, before or after resection or ablation.
12. Participants receiving or expected to receive IFN-based therapies during the study period.
13. Positive pregnancy test.
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.<br>• 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;Timepoint(s) of evaluation of this end point: RFS will be evaluated on an ongoing basis from randomization until recurrence
- 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).<br>• Time to Recurrence (TTR), defined as the time from randomization to the first documented disease recurrence ;Timepoint(s) of evaluation of this end point: OS: From the beginning of randomization period up to date of event<br>TTR: time from randomization to the first documented disease recurrence