A study of nivolumab and ipilimumab in combination with Transarterial ChemoEmbolization (TACE) in participants with intermediate stage liver cancer (CheckMate 74W)
- Conditions
- Intermediate-stage Hepatocellular Carcinoma (HCC)MedDRA version: 21.1Level: LLTClassification code 10049010Term: Carcinoma hepatocellularSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-002790-58-BE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 765
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method