bevacizumab Sponsor: ARCAGY-GINECO Principal Investigator : Pr Jean - - PowerPoint PPT Presentation

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Aug 20, 2022 293 likes •343 views

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

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Sponsor: ARCAGY-GINECO

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 ATezolizumab and Avastin in LAte recurreNT diseasE

Principal Investigator : Pr Jean Emmanuel Kurtz; CHRU Strasbourg Scientific Coordinator: Pr Eric Pujade-Lauraine

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50 100 150 200 250 300 350 400 450

ct-16

janv-17 apr-17 juil-17

ct-17

janv-18 apr-18 juil-18

ct-18

janv-19

Recruitment curve

Cumul screening Cumul rando Rando theo

92 randomized patients / 119 screened (only in France)

20 40 60 80 100 120

Nb screening Cumul screening Nb rando Cumul rando

32 sites actives / 39 sites opened

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Safety analyses ▪ 1st 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 ▪ 2nd IDMC on 45 first patients who have received 2 cycles is planned in June 2017 Amendement Protocol was amended in April 2017 following the 1st IDMC. Approvals are expected in June. Launch on an international level planned in September 2017