PT  - JOURNAL ARTICLE
AU  - Philipp Harter
AU  - Patricia Pautier
AU  - Els Van Nieuwenhuysen
AU  - Alexander Reuss
AU  - Andres Redondo
AU  - Kristina Lindemann
AU  - Christian Kurzeder
AU  - Edgar Petru
AU  - Florian Heitz
AU  - Jalid Sehouli
AU  - Nikolaus Degregorio
AU  - Pauline Wimberger
AU  - Alexander Burges
AU  - Nadin Cron
AU  - Jonathan Ledermann
AU  - Domenica Lorusso
AU  - Xavier Paoletti
AU  - Frederik Marme
TI  - 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)
AID  - 10.1136/ijgc-2020-001572
DP  - 2020 Jun 30
TA  - International Journal of Gynecologic Cancer
PG  - ijgc-2020-001572
4099  - http://ijgc.bmj.com/content/early/2020/06/30/ijgc-2020-001572.short
4100  - http://ijgc.bmj.com/content/early/2020/06/30/ijgc-2020-001572.full
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.