AT ezolizumab and A vastin in LA te recurre NT diseas E A randomized, double blinded, phase III study of atezolizumab versus placebo in patients with late relapse of epithelial ovarian, fallopian tube, or peritoneal cancer treated by platinum-based chemotherapy and bevacizumab Sponsor: ARCAGY-GINECO Principal Investigator : Pr Jean Emmanuel Kurtz; CHRU Strasbourg Scientific Coordinator: Pr Eric Pujade-Lauraine
Recruitment curve 450 400 350 300 92 randomized patients / 119 screened 250 (only in France) 200 150 100 50 0 oct-16 janv-17 apr-17 juil-17 oct-17 janv-18 apr-18 juil-18 oct-18 janv-19 Cumul screening Cumul rando Rando theo 120 100 80 32 sites actives / 39 sites opened Nb screening 60 Cumul screening Nb rando 40 Cumul rando 20 0
Safety analyses ▪ 1 st IDMC on 36 first patients who have received 1 cycle has been performed on March 2017 There are no safety concern in comparison with chemotherapy alone ▪ 2 nd IDMC on 45 first patients who have received 2 cycles is planned in June 2017 Amendement Protocol was amended in April 2017 following the 1 st IDMC. Approvals are expected in June. Launch on an international level planned in September 2017
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