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358 Phase 3 trial of tumor treating fields concomitant with weekly paclitaxel for platinum-resistant ovarian cancer: ENGOT-ov50/GOG-329/INNOVATE-3
  1. I Vergote1,
  2. V Salutari2,
  3. D Cibula3,
  4. J Korach4,
  5. EP Samartzis5,
  6. J Sehouli6,
  7. R Fossati7,
  8. AG Martin8,
  9. I Tsibulak9,
  10. B Slomovitz10,
  11. R Coleman11,
  12. B Monk12,
  13. P Thaker13 and
  14. D O’Malley14
  1. 1Leuven Cancer Institute, Belgium
  2. 2Fondazione Policlico Universitario Agostino Gemelli, Italy
  3. 3Charles University Hospital, Czech Republic
  4. 4Chaim Sheba Medical Center, Israel
  5. 5Universitätsspital Zürich, Switzerland
  6. 6Charité Frauenklinik, Germany
  7. 7IRCCS-Istituto di Ricerche Farmacologiche, Italy
  8. 8Clinical Universidad de Navarra, Spain
  9. 9Medical University Innsbruck, Austria
  10. 10University of Miami, Sylvester Comprehensive Cancer Center, USA
  11. 11MD Anderson Cancer Center, USA
  12. 12University of Arizona College of Medicine, USA
  13. 13Washington University Gynecological Oncology, USA
  14. 14Ohio State University Comprehensive Cancer Center, USA


Background Tumor Treating Fields (TTFields) are a non-invasive, antimitotic cancer therapy. The Phase 2 INNOVATE study demonstrated safety of TTFields/weekly paclitaxel in 31 PROC (platinum-resistant ovarian cancer) patients (Vergote Gyn Onc 2018); efficacy: median PFS 8.9 months, 25% partial response,71% clinical benefit and 61% 1-year survival rate. This phase 3 ENGOT-ov50/GOG-329/INNOVATE-3 study [NCT03940196] investigates TTFields plus weekly paclitaxel in PROC patients.

Study Design Patients (N=540) will have PROC (RECIST V1.1) within 6 months of last platinum therapy with maximum of 2–5 prior lines of systemic therapy, ECOG 0–1 and no peripheral neuropathy >grade1. Patients with primary refractory disease will be excluded. Patients will be randomized 1:1 to weekly paclitaxel alone or weekly paclitaxel (starting of dose 80 mg/m2 weekly for 8 weeks, and then on Days 1, 8, and 15 for subsequent 28-day cycle ) plus TTFields (200 kHz for 18 hours/day and continued if no progression in the abdominal or pelvic regions (‘in-field region’) per RECIST V1.1. Clinical follow-up will be performed q4w, with radiological follow-up (CT or MRI scans of the abdomen and chest) q8w. The primary endpoint is overall survival. Secondary endpoints: PFS, objective response rate, AEs, and quality of life (EORTC QLQ-C30 with QLQ-OV28). Sample size (n=540) will detect an increase in median OS from 12 to 16 months (HR 0.75). Data Monitoring Committee (DMC) meeting (March 2020) concluded that data to-date showed no safety issues and recommended trial continuation.

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