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, 970 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. The trial is currently recruiting, the first patient was randomized in October 2022.

Results Trial-In-Progress

Conclusion Trial-In-Progress

Disclosures Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Study Group is the sponsor of the trial. Financial support and drug supply by GSK.

Author Disclosure Information F. HEITZ: Honoraria or consultation fees (AstraZeneca, GSK, Roche, Tesaro, MSD); E. PETRU: Honorary for lectures (AGEA, Amgen, Astra Zeneca, Angelini, Eisai, Eli Lilly, Glaxo Smith Kline, MSD, Novartis, Pharma Mar, Pfizer, Roche, Seagen, GILEAD, Pierre Fabre), Honorary for advisory boards (Amgen, Astra Zeneca, Angelini, Eisai, Eli Lilly, Glaxo Smith Kline, MSD, Novartis, Pharma Mar, Pfizer, Roche, Clovis, Daiichi Sankyo, Seagen, GILEAD, Pierre Fabre), Honorary - Institution (Amgen, Astra Zeneca, Angelini, Eli Lilly, Glaxo Smith Kline, Novartis, Pharma Mar, Pfizer, Roche, TESARO, Pierre Fabre), Travel expenses (AGEA, Amgen, Astra Zeneca, Glaxo Smith Kline, Pharma Mar, Pfizer, Roche, Pierre Fabre); S. HENRY: None; A. REUSS: None; D. CIBULA: None; L. GABA: Honoraria or consultation fees (GSK, MSD, AstraZeneca, PharmaMar, Clovis Oncology), Participation in a company sponsored speaker’s bureau (GSK, MSD, AstraZeneca, PharmaMar, Clovis Oncology), Attending meetings or traveling (GSK, MSD, AstraZeneca, PharmaMar, Clovis Oncology); N. COLOMBO: Consultant/Advisor (Roche, PharmaMar, AstraZeneca, Clovis Oncology, MSD, GSK, Tesaro, Pfizer, BIOCAD, Immunogen, Mersana, Eisai, Oncxerna, Nuvation Bio), Promotional Speaker (AstraZeneca, Tesaro, Novartis, Clovis Oncology, MSD, GSK, Eisai), Investigator/Researcher (AstraZeneca, PharmaMar, Roche), Non-financial interests (Steering Committee Member for ESMO Clinical Guidelines, Chair Scientific Committee ACTO onlus); S. POLLEIS: None; P. HARTER: Grants/Research supports (AstraZeneca, Roche, GSK, Genmab, Immunogen, Seagen, Clovis Oncology, Novartis), Honororia or consultation fees (Amgen, AstraZeneca, Clovis Oncology, Eisai, Exscientia, GSK, Immunogen, Mersana, Miltenyi, MSD, Roche, Sotio, Stryker)