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624 NOGGO Ov-42/MAMOC: rucaparib MAintenance after bevacizumab maintenance following carboplatin based first line chemotherapy in OvCA patients
  1. E Braicu1,
  2. P Wimberger2,
  3. A Relógio3,4,
  4. J Dysarz5,
  5. J Gerber6,
  6. M Eichbaum7,
  7. M Deryal8,
  8. R Chekerov1,
  9. J Grabowksi1,
  10. M Rose9,
  11. M Endres10,
  12. C Scheibenbogen1,
  13. H Woopen1 and
  14. J Sehouli1
  1. 1Charité Universitätsmedizin Berlin, Klinik für Gynäkologie, Campus Virchow Klinikum, Berlin, Germany
  2. 2Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Dresden, Germany
  3. 3Systems Biology of Cancer Molecular Cancer Research Center (MKFZ), Institute for Theoretical Biology (ITB) Charité – Universitätsmedizin Berlin, Berlin, Germany
  4. 4Department of Human Medicine, Institute for Systems Medicine, MSH Medical School Hamburg, Germany
  5. 5NOGGO e.V. Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie, Berlin, Germany
  6. 6Städtisches Klinikum Dessau, Klinik für Frauenheilkunde und Geburtshilfe, Dessau, Germany
  7. 7Helios Dr. Horst Schmidt Kliniken Wiesbaden, Klinik für Frauenheilkunde und Geburtshilfe, Wiesbaden, Germany
  8. 8Caritas Klinikum Saarbrücken, Zentrum für Geburtshilfe und Frauenheilkunde, Saarbrücken, Germany
  9. 9Charité Universitätsmedizin Berlin, Medizinische Klinik m.S. Psychosomatik, Campus Benjamin Franklin, Berlin, Germany
  10. 10Charité Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie, Berlin, Germany


Introduction/Background*Ovarian cancer (OC) is associated with the highest mortality rates among gynecological malignancies, with most patients being diagnosed in advanced stages. The most common histological subtype is high grade serous OC, which is characterized by deficiency in homologous recombination. Debulking surgery, followed by platinum based chemotherapy and bevacizumab (bev), followed by maintenance therapy with bev, is the standard therapy for advanced BRCA wild type (BRCAwt) OC patients in Germany. BRCA mutant patients will receive maintenance with olaparib, according to SOLO1 data. The anticancer effects of PARP inhibitors (PARPi) seem to be increased by the addition of antiangiogenic drugs. Preclinical data showed increased HRD in tumors pretreated with bev, and clinical trials showed a benefit of the combination of antiangiogenic drugs and PARPi vs. PARPi alone. NOGGO Ov-42/MAMOC trial (NCT04227522) is a phase 3, randomized, placebo-controlled study evaluating rucaparib maintenance following bevacizumab maintenance for the treatment of advanced primary high grade BRCAwt OC.

Methodology 190 patients with histologically confirmed advanced (FIGO stage IIIA- IV of the 2014 FIGO classification) high grade serous or high grade endometrioid (based on local histopathological findings) OC, fallopian tube cancer, primary peritoneal cancer or clear cell carcinoma of the ovary will be randomized 2:1 to receive either rucaparib 600mg BID or placebo as maintenance therapy following first line chemotherapy with 6 cycles of Carboplatin/Paclitaxel and at least 12 cycles of bev, given together with chemotherapy and as maintenance. Only BRCAwt patients will be included in the trial. Randomization is stratified by surgery planned timepoint (neoadjuvant vs. adjuvant), surgical outcome (no residual tumor mass vs. residual tumor mass), response to chemotherapy followed by bev (CR/NED vs. PR/SD) and study center. Treatment will continue for 24 months or until disease progression, unacceptable toxicity, or withdrawal. Primary endpoint is PFS in BRCAwt patients per RECIST v1.1. Secondary endpoints are PFS2, quality of life (EORTC QLQ-C30/OV28, Fatigue Symptom Inventory, SF-12, PROC-CTCAE, Everyday Memory Questionnaire), daily activity, time to next medical intervention, time to next subsequent therapy, safety assessments and OS. At the moment 8 patients are randomized.

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