A Phase 3 Study of ONO-4538(ONO-4538-56/CA209901)
Phase 3
Completed
- Conditions
- rothelial carcinoma
- Registration Number
- JPRN-jRCT2080223696
- Lead Sponsor
- ONO PHARMACEUTICAL CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1290
Inclusion Criteria
1. Metastatic or inoperable urothelial cancer
2. Must have at least 1 lesion with measurable disease
3. No prior systemic chemotherapy treatment in the metastatic setting
Exclusion Criteria
1. Patients with active brain metastases or leptomeningeal metastases
2. Patients with active, known or suspected autoimmune disease
3. Prior treatment with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137, or anti-CTLA4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method