RT Journal Article SR Electronic T1 Atezolizumab in combination with bevacizumab and chemotherapy versus bevacizumab and chemotherapy in recurrent ovarian cancer – a randomized phase III trial (AGO-OVAR 2.29/ENGOT-ov34) JF International Journal of Gynecologic Cancer JO Int J Gynecol Cancer FD BMJ Publishing Group Ltd SP ijgc-2020-001572 DO 10.1136/ijgc-2020-001572 A1 Philipp Harter A1 Patricia Pautier A1 Els Van Nieuwenhuysen A1 Alexander Reuss A1 Andres Redondo A1 Kristina Lindemann A1 Christian Kurzeder A1 Edgar Petru A1 Florian Heitz A1 Jalid Sehouli A1 Nikolaus Degregorio A1 Pauline Wimberger A1 Alexander Burges A1 Nadin Cron A1 Jonathan Ledermann A1 Domenica Lorusso A1 Xavier Paoletti A1 Frederik Marme YR 2020 UL http://ijgc.bmj.com/content/early/2020/06/30/ijgc-2020-001572.abstract AB Background Improvement in clinical outcomes of patients with platinum-resistant disease is an unmet medical need and trials in this population are urgently needed. Checkpoint-inhibitors have already shown activity in multiple other tumor entities and ovarian cancer, especially in the combination with anti-angiogenic treatment.Primary objective To test if the activity of non-platinum-based chemotherapy and bevacizumab could be improved by the addition of atezolizumab.Study hypothesis The addition of atezolizumab to standard non-platinum combination of chemotherapy and bevacizumab improves median overall survival from 15 to 20 months.Trial design Patients are randomized to chemotherapy (paclitaxel weekly or pegylated liposomal doxorubicin) + bevacizumab + placebo vs chemotherapy + bevacizumab + atezolizumab. Stratification factors are: number of prior lines, planned type of chemotherapy, prior use of bevacizumab, and tumor programmed death-ligand 1 (PD-L1) status.Major inclusion/exclusion criteria Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer with up to three prior therapies and a treatment-free interval after platinum of less than 6 months. Patients with three prior lines of chemotherapy are eligible irrespective of the platinum free-interval. A de novo tumor tissue sample biopsy for determination of PD-L1 status prior to randomization for stratification is mandatory. Major exclusion criteria consider bevacizumab-specific and immunotherapy-specific criteria.Primary endpoint Overall survival and progression-free survival are co-primary endpoints.Sample size It is planned to randomize 664 patients.Trial registration NCT03353831.