Open-Label, Multicenter, Ph 3 Study to Evaluate the Efficacy and Tolerability of Intravesical Vicinium in Subjects With Non Muscle-Invasive Carcinoma in Situ and/or High-Grade Papillary Disease of the Bladder Treated With BCG
Phase of Trial: Phase III
Latest Information Update: 11 Nov 2017
At a glance
- Drugs Oportuzumab monatox (Primary)
- Indications Bladder cancer
- Focus Registrational; Therapeutic Use
- Sponsors Eleven Biotherapeutics; Viventia Biotechnologies
- 14 Aug 2017 According to an Eleven Biotherapeutics media release, topline three-month data from this trial is expected in mid-2018 and topline 12-month data is now expected in second quarter of 2019.
- 14 Aug 2017 According to an Eleven Biotherapeutics media release, the company anticipates complete enrollment of this trial in the first quarter of 2018.
- 01 Jun 2017 According to an Eleven Biotherapeutics media release, this trial has exceeded 50% enrollment, and the independent Data and Safety Monitoring Board (DSMB) for the trial has recommended that the trial continue as planned. Topline 3-month data from this trial are expected in 2Q2018.