Phase 1/2 study of Relatlimab and Nivolumab in Combination with Bevacizumab in First-line HCC (CA224-106)
Active, not recruiting
- Conditions
- Hepatocellular Carcinoma
- Registration Number
- jRCT2031220213
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Participants must have histologic confirmation of advanced/metastatic HCC Naive to systemic therapy for advanced/metastatic HCC Must have at least one Response Evaluation Criteria in Solid Tumors(RECIST)v1.1 measurable untreated lesion Child-Pugh score of 5 or 6 Eastern Cooperative Oncology Group(ECOG)performance status 0 or 1 for ECOG performance status scale
Exclusion Criteria
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC Prior allogenic stem cell or solid organ transplantation Prior disease history with increased risk of bleeding Uncontrolled or significant cardiovascular disease Participants with an active, known or suspected autoimmune disease.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - DLT assessment
PFS assessed by BICR
- Secondary Outcome Measures
Name Time Method