A Phase 3 Study of ONO-4538/BMS-936558(ONO-4538-40/CA209548)
Phase 3
Completed
- Conditions
- Glioblastoma
- Registration Number
- JPRN-jRCT2080223128
- Lead Sponsor
- ONO PHARMACEUTICAL CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 693
Inclusion Criteria
1. Newly-diagnosed GBM
2. Tumor test result shows MGMT methylated or indeterminate tumor subtype
3. Karnofsky performance status of >= 70 (able to care for self)
4. Substantial recovery from surgical resection
Exclusion Criteria
1. Biopsy-only of GBM with less than 20% of tumor removed
2. Prior treatment for GBM (other than surgical resection)
3. Any known tumor outside of the brain
4. Recurrent or secondary GBM
5. Active known or suspected autoimmune disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Progression free survival (PFS), Blinded Independent Central Review(BICR) assessed, Overall survival (OS)
- Secondary Outcome Measures
Name Time Method efficacy<br>Overall survival rate at 24 months (OS[24]), <br>Progression free survival (PFS), Investigator assessed