A Phase 3 Study of ONO-4538/BMS-936558 (CA209459/ONO-4538-35)
Phase 3
Completed
- Conditions
- Advanced Hepatocellular Carcinoma
- Registration Number
- JPRN-jRCT2080223055
- Lead Sponsor
- ONO PHARMACEUTICAL CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 726
Inclusion Criteria
1. Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical and/or locoregional therapies; or progressive disease after surgical and /or locoregional therapies
2. Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4 weeks prior to the baseline scan
3. Child-Pugh Class A
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria
1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
2. Prior liver transplant
3. Active, known, or suspected autoimmune disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>1. Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method efficacy<br>1. Overall Response Rate (ORR)<br>2. Progression-Free Survival (PFS)<br>3. PD-L1 expression