A phase II/III study of ONO-4538 (ONO-4538-37)
Phase 2
Completed
- Conditions
- Gastric cancer
- Registration Number
- JPRN-jRCT2080223111
- Lead Sponsor
- ONO PHARMACEUTICAL CO.,LTD.
- Brief Summary
ivolumab combined with oxaliplatin-based chemotherapy significantly improved progression-free survival, but not overall survival, in Asian patients with untreated, HER2-negative, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer, and could potentially be a new first-line treatment option for these patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 724
Inclusion Criteria
1. ECOG Performance Status score 0 or 1
2. Life expectancy of at least 3 months
3. Have measurable lesions as defined in RECIST ver. 1.1
Exclusion Criteria
1. Have multiple cancers
2. Have a current or past history of severe hypersensitivity to any other antibody products
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Progression free survival, Overall survival
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Objective response rate, safety, etc.