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TP011/#1536  A double-blind placebo-controlled phase III chemo-immunotherapy (Paclitaxel-carboplatin-oregovomab [PCO]) vs chemotherapy (Paclitaxel-carboplatin-placebo [PCP]) in patients with newly diagnosed, advanced epithelial ovarian cancer (EOC): FLORA-5/GOG-3035 study
  1. Myong Cheol Lim1,
  2. Yong-Man Kim2,
  3. Sunil Gupta3,
  4. Srinivasa Rao Jada3,
  5. Jung-Yun Lee4,
  6. Lucy Gilbert5,
  7. Michael Gold6,
  8. Casey Cosgrove7,
  9. Babak Edraki8,
  10. Joyce N Barlin9,
  11. Lukas Rob10,
  12. Diane Provencher11,
  13. David O’Malley12 and
  14. Angeles Alvarez Secord13
  1. 1Center for Gynecologic Cancer, National Cancer Center, Department of Obstetrics and Gynecology, Goyang, Korea, Republic of
  2. 2Gynecologic Cancer Center, Asan Cancer Institute, Asan Medical Center, University of Ulsan, Dept. of Obstetrics and Gynecology, Seoul, Korea, Republic of
  3. 3CanariaBio Inc, Clinical Development, Seoul, Korea, Republic of
  4. 4Yonsei University Health System, Obstetrics and Gynecology, Seoul, Korea, Republic of
  5. 5McGill University Health Centre, Department of Gynecologic Oncology, Montreal, Canada
  6. 6Oklahoma Cancer Specialists and Research Institute, Department of Gynecologic Oncology, Tulsa, USA
  7. 7The Ohio State University, Gynecologic Oncology, Columbus, USA
  8. 8John Muir Health, Gyenecologic Oncology, California, USA
  9. 9Women‘s Cancer Care Associates, Gyenecologic Oncology, New York, USA
  10. 10Fakultni nemocnice Kralovske Vinohrady Czech Republic, Gyenecologic Oncology, Prague, Czech Republic
  11. 11CHUM Centre de Recherche, Gyenecologic Oncology, Montreal, Canada
  12. 12The Ohio State University and The James Cancer Center, Division of Gynecologic Oncology In Obstetrics and Gynecology, Columbus, USA
  13. 13Duke University, Gynecologic Oncology, Durham, USA


Introduction Oregovomab, a murine IgGκ1 MAb, binds to the circulating tumor associated antigen CA125, resulting in development of immunogenic complexes with CA125, which are subsequently processed by dendritic cells and macrophages leading to downstream CA125-specific antitumor activity by T and B lymphocytes. In a randomized Phase 2 study in previously untreated EOC patients, immunization with oregovomab with paclitaxel and carboplatin (PC) demonstrated significant improvement in mPFS (months) 41.8 for PCO and 12.2 for PC (p = 0.0027, HR 0.46) and mOS has not yet been reached (NE) for PCO and was 43.2 months for PC (p = 0.043, HR 0.35).

Methods This Phase 3, double-blind, placebo-controlled, multicenter trial, has enrolled patients from 14 countries. Patients with optimally debulked with FIGO III/IV EOC and serum CA125 ≥ 50 U/ml receiving adjuvant (Cohort 1) or neoadjuvant (Cohort 2) chemotherapy were randomized post-surgery to PCO or PCP. Patients with germline BRCA1/2 mutations were excluded. Chemotherapy will be administered every 3 weeks in both cohorts. In cohort 1, oregovomab/placebo is administered simultaneously at cycles 1, 3, and 5 of chemotherapy with an additional dose at 12 weeks following cycle 5. In cohort 2, oregovomab/placebo is administered post interval debulking surgery at cycles 4 and 6 with an additional dose at 6- and 18-weeks following cycle 6. The primary objective is PFS determined by RECIST 1.1 criteria.

Current Trial Status At the time of abstract submission, 618 patients were enrolled and target enrolment Cohort 1 (378) and Cohort 2 (240) was achieved.

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