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Prima BioMed Receives Regulatory Scientific Advice on CVac Phase III Trial
Date:2/18/2011

conducted after 468 deaths.

An independent Data and Safety Monitoring Board (DSMB) will assess blinded safety measures and demographics at regular intervals throughout the study or as determined by the DSMB chair. The DSMB will also review interim irPFS data, unblinded at the group level, after 200 irPFS events. At the time of interim sample size review, the DSMB may recommend changes to the sample size or early termination of the study for efficacy or safety reasons as detailed in the protocol.

Key DatesFirst patient recruited Q3 2011

Interim data analysis* Q4 2012 - 1Q 2013

Final data analysis * Q4 2013 - 1Q 2014

*As an event driven study with adaptable design to have the flexibility after interim analysis to adjust patient size and study duration. Precise timelines are driven by these events of study patient progression free survival and/or overall survival and this can only be indicative.

Study SummaryThe purpose of this study is to determine whether CVac™ is effective in the treatment of Patients With Epithelial Ovarian Cancer (EOC) Following Optimal Debulking Surgery and First-line Chemotherapy as assessed by progression free survival or overall survival.

EndpointsPrimary Objectives

  • To assess the efficacy, in terms of immune-related progression-free survival (irPFS), of CVac™ as compared with placebo for maintenance treatment in patients with epithelial ovarian cancer (EOC) following optimal debulking surgery and first-line chemotherapy
  • To assess the efficacy, in terms of overall survival (OS), of CVac as compared with placebo for maintenance treatment in patients with EOC following optimal debulking surgery and first-line chemotherapy.

  • Secondary Objectives

  • To assess the safety and tolerability of CVac™ as compared with placebo
  • To assess health-related quality of life (QoL) related to CVac treatment as compared with plac
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  • SOURCE Prima BioMed Ltd
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