A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined With Bevacizumab vs. Bevacizumab Monotherapy in Patients With Recurrent Glioblastoma
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 02 Oct 2017
At a glance
- Drugs Ofranergene obadenovec (Primary) ; Bevacizumab
- Indications Glioblastoma
- Focus Registrational; Therapeutic Use
- Acronyms GLOBE
- Sponsors VBL Therapeutics
- 02 Oct 2017 According to a VBL Therapeutics media release, the company expects to have top-line results from the study to be available in Q1 2018.
- 02 Oct 2017 According to a VBL Therapeutics media release, the independent Data Safety Monitoring Committee (DSMC) has conducted the third and final review of the trial and stated that they did not identify any safety concerns. DSMC confirmed that no additional follow up will be necessary and unanimously recommended that the study continue as planned, to completion.
- 14 Aug 2017 According to a VBL Therapeutics media release, the company expect a final Data Safety Monitoring Committee (DSMC) review in late September and top-line data in Q1 2018.Based on interactions of the company with the FDA and the SPA for the trial, this trial should support a Biologics License Application (BLA).