TP021/#1521 FLORA-5/GOG3035: chemo-immunotherapy (paclitaxel and carboplatin ± oregovomab) as front-line treatment for patients with ovarian cancer. A phase III double blind placebo controlled, global multicenter study. (4th December 2022)

• Record Type: Journal Article
• Authors: Alvarez Secord, Angeles; Barroilhet, Lisa; Cheol Lim, Myong; Oosman, Sonia; Gupta, Sunil; Jada, Srinivasa; Gold, Michael; Gilbert, Lucy; Barlin, Joyce; Edraki, Babak; Tewari, Devansu; Provencher, Diane; Kim, Yong Man; Bixel, Kristin; O'Malley, David
• Is Part Of: International journal of gynecological cancer. Volume 32(2022)Supplement 3
• Page Start: A233
• Page End: A234
• Publication Date: 2022-12-04
• Subjects: Generative organs, Female -- Cancer -- Periodicals; 616.99465
• DOI: 10.1136/ijgc-2022-igcs.530
• Languages: English
• ISSNs: 1048-891X

Abstract

Abstract : Objectives: Oregovomab (O), a murine IgG? monoclonal antibody binds to tumor-associated antigen, CA125, rendering target CA125 more immunogenic through enhanced antigen processing and presentation to specific T cells, bypassing tumor-associated suppression and resulting in enhanced efficacy of chemotherapy. In a randomized phase II study, oregovomab in combination with paclitaxel and carboplatin (PC) demonstrated significant improvement in PFS (median (months) 41.8 PCO vs 12.3 PC, HR=0.46, p=0.0027 and OS median N.E. PCO vs 43.2 PC, HR=0.35, p=0.043. FLORA-5/GOG-3035 is the confirmatory global registration trial. Methods: Optimally debulked patients with FIGO III/IV epithelial ovarian cancer and serum CA125 > 50 U/ml randomized to PC ± oregovomab. Patients with BRCA1/2 mutations are excluded. Chemotherapy will be administered every 3 weeks in two cohorts. In Cohort 1 (adjuvant), oregovomab/placebo is administered at cycles 1, 3, and 5 of chemotherapy and at 12 weeks following cycle 5. In Cohort 2 (neoadjuvant), oregovomab/placebo will be administered at cycles 4 and 6 of chemotherapy, and at 6- and 18-weeks following cycle 6. No other post front-line maintenance therapy is permitted. The primary objective is PFS by RECIST 1.1 criteria. Cohort 1 will recruit 372 patients and Cohort 2 will recruit 230 patients. Secondary objectives include OS, frequency and severity of adverse events, and quality of life. 137 sites in US, Canada Asia, Europe and South American are actively enrolling. 324 patients have been randomized. Results: Trial in progress: there are no available results at time of submission. Conclusions: Trial in progress: there are no available conclusions at time of submission.