drugset / Trial / NCT03149003
A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an event driven, adaptive design, a randomized, active-controlled, multicenter, open-label, parallel groups, Phase 3 study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma multiforme (GBM) following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy.
Timeline
- Start
- 2017-12-08
- Primary completion
- 2021-08-30
- Completion
- 2021-08-30
Outcome
Missed primary endpoint
release “patients with recurrent or progressive glioblastoma (GBM) will terminate following its second interim analysis after determining there is a low probability of meeting the primary” sumitomo-pharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | ombipepimut-S | Vaccine | — | Other |