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2022-RA-909-ESGO AGO-OVAR 28/ENGOT-ov57: niraparib vs niraparib in combination with bevacizumab in patients with carboplatin-taxane based chemotherapy in advanced ovarian cancer (a multicentre randomised phase III trial)
  1. Florian Heitz1,
  2. Christian Marth2,
  3. Stéphanie Henry3,
  4. Alexander Reuss4,
  5. David Cibula5,
  6. Lydia Gaba6,
  7. Nicoletta Colombo7,
  8. Sandra Polleis8 and
  9. Philipp Harter1
  1. 1AGO Study Group and Ev. Kliniken Essen-Mitte, Essen, Germany
  2. 2AGO-Austria and Medical University of Innsbruck, Innsbruck, Austria
  3. 3BGOG and CHU UCL Namur Site Sainte Elisabeth, Namur, Belgium
  4. 4AGO Study Group and Coordinating Center for Clinical Trials, Philipps-University of Marburg, Marburg, Germany
  5. 5CEEGOG and General University Hospital in Prague, Prague, Czech Republic
  6. 6GEICO and Hospital Clinic of Barcelona, Barcelona, Spain
  7. 7MANGO and IEO, European Institute of Oncology, IRCCS, Milan and University of Milano-Bicocca, Milan, Italy
  8. 8AGO Study Group, Wiesbaden, Germany


Introduction/Background Standard of care chemotherapy in patients (pts) with advanced ovarian cancer (AOC) is the combination of carboplatin and paclitaxel (C/P). Data from the PRIMA trial has shown a significant benefit in pts by the addition of a maintenance treatment (MT) with niraparib irrespective of BRCA or HRD-status in high-grade AOC. The PAOLA-1 trial evaluated MT in pts with AOC with the combination of olaparib and bevacizumab and has also shown a significant benefit compared to bevacizumab monotherapy. However, the role/benefit of bevacizumab in addition to PARP-inhibitor (PARPi) in MT is unclear. Therefore, we investigate, if the treatment strategy of carboplatin/paclitaxel/bevacizumab/PARPi is superior to the treatment of carboplatin/paclitaxel/PARPi in a population regardless of biomarker status.

Methodology AGO-OVAR 28/ENGOT-ov57 (NCT05009082; EudraCT-Number: 2021–001271–16) is a multicenter, randomized, prospective phase III trial. The trial population is composed of adult pts with newly diagnosed, high-grade epithelial AOC, primary peritoneal cancer or fallopian tube cancer FIGO III/IV (except FIGO IIIA2 without nodal involvement). All pts should have completed cycle1 of chemotherapy (C/P) as part of Study-Run-In-Period. Prior to day1 of cycle2, pts with a valid central tumor BRCA (tBRCA) test result will be randomized 1:1 into either Arm1 and will receive 5 additional cycles of C/P q21d followed by niraparib for up to 3 years; or into Arm2 where pts will receive 5 additional cycles of C/P plus bevacizumab q21d followed by bevacizumab q21d (for up to 1 year) and niraparib for up to 3 years. Patients who are scheduled for neoadjuvant chemotherapy and interval debulking surgery can also be enrolled. The primary objective is progression-free-survival (PFS). Secondary objectives include but are not limited to: PFS according to tBRCA-status, overall survival, PFS2, safety/tolerability, and quality of life. First-Patient-First-Visit is expected in August 2022. Target recruitment is 970 patients.

Results Trial-In-Progress.

Conclusion Trial-In-Progress.

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