drugset / Trial / NCT03149003

A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy

NCT03149003 ↗

Phase 3 Completed 221 enrolled Sumitomo Pharma America, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject ombipepimut-S Vaccine — Other

Indications