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

Trial Profile

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Oct 2017

At a glance

  • Drugs Oportuzumab monatox (Primary)
  • Indications Bladder cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Eleven Biotherapeutics; Viventia Biotechnologies
  • Most Recent Events

    • 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.
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