Intermediate-stage Hepatocellular Carcinoma (HCC) MedDRA version: 21.1 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular System Organ Class: 100000004864
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Participant has intermediate-stage HCC (hepatocellular carcinoma) whose tumor characteristics exceed the BMU7 criteria and is eligible for TACE b) Participant has histologic confirmation of HCC c) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 d) Men and Women must agree to follow methods of contraception e) Participants are eligible to enroll if they have non-viral related HCC, or if they have HBV-HCC, or HCV-HCC Other protocol defined inclusion/exclusion criteria could apply. 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 650 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 115
Exclusion criteria
Exclusion criteria: a) Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC b) Prior liver transplant or participants who are on the waiting list for liver transplantation c) Active, known, or suspected autoimmune disease d) Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications e) Any previous TACE or TAE (trans-arterial embolization without instillation of chemotherapy agent) procedure for HCC f) Known or suspected allergy to nivolumab, ipilimumab, or study drug components given in association with this trial Other protocol defined inclusion/exclusion criteria could apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To compare TTTP of nivolumab and ipilimumab plus TACE (Arm A) to nivolumab placebo and ipilimumab placebo plus TACE (Arm C) in all randomized participants. 2) To compare the OS of Arm A to Arm C in all randomized participants.;Secondary Objective: 1) To compare TTTP of nivolumab and ipilimumab placebo plus TACE (Arm B) to Arm C in all randomized participants. 2) To compare the OS of Arm B to Arm C in all randomized participants. 3) To compare EFS of Arm A vs Arm C and Arm B vs Arm C in all randomized participants. 4) To compare PFS of Arm A vs Arm C and Arm B vs Arm C in all randomized participants.;Primary end point(s): 1) Time to TACE progression (TTTP) will be assessed by the blinded independent central review (BICR): Arm A versus Arm C 2) Overall survival (OS): Arm A versus Arm C;Timepoint(s) of evaluation of this end point: 1) Time to TACE progression (TTTP) - up to 2 years 2) Overall survival (OS): up to 2.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Time to TACE progression (TTTP) will be assessed by the blinded independent central review (BICR): Arm B versus Arm C 2) Overall Survival (OS): Arm B versus Arm C 3) Event-Free Survival (EFS) 4) Progression-free survival (PFS);Timepoint(s) of evaluation of this end point: 1) Time to TACE progression (TTTP): up to 2 years 2) Overall Survival (OS): up to 2.5 years 3) Event-Free Survival (EFS): up to 2 years 4) Progression-free survival (PFS): up to 2 years | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Poland, Puerto Rico, Russian Federation, Singapore, Spain, Switzerland, Taiwan, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed