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)

Philipp Harter, Patricia Pautier, Els Van Nieuwenhuysen, Alexander Reuss, Andres Redondo, Kristina Lindemann, Christian Kurzeder, Edgar Petru, Florian Heitz, Jalid Sehouli, Nikolaus Degregorio, Pauline Wimberger, Alexander Burges, Nadin Cron, Jonathan Ledermann, Domenica Lorusso, Xavier Paoletti, Frederik Marme

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)1997-2001
Number of pages5
JournalInternational Journal of Gynecological Cancer
Volume30
Issue number12
DOIs
Publication statusPublished - Dec 1 2020

Keywords

  • ovarian cancer

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynaecology

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