Study to evaluate the safety and efficacy of nivolumab combined with ipilimumab as first-line (1L) therapy for participants with advanced HCC
- Conditions
- Hepatocellular CarcinomaMedDRA version: 21.1Level: LLTClassification code 10049010Term: Carcinoma hepatocellularSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA 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
- EUCTR2019-000252-34-PL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 650
- Participants must have a diagnosis of HCC based on histological confirmation
- Participants must have an advanced HCC
- Participants must have at least one Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 measurable previously untreated lesion
- Child-Pugh score 5 or 6
- 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 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Prior liver transplant
- Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
- Active brain metastases or leptomeningeal metastases
Other protocol inclusion/exclusion criteria may 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