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EPV255/#120 Tisotumab vedotin vs investigator’s choice chemotherapy in second- or third-line recurrent or metastatic cervical cancer (innovatv 301/ENGOT-CX12/GOG-3057, trial in progress)
  1. I Vergote1,
  2. LM Randall2,
  3. E Kalbacher3,
  4. K Madsen4,
  5. E Van Nieuwenhuysen1,
  6. A González-Martín5,
  7. D Cibula6,
  8. B Monk7,
  9. L Woelber8,
  10. S Banerjee9,
  11. A Westermann10,
  12. N Colombo11,
  13. D Lorusso12,
  14. P Calvert13,
  15. RL Coleman14,
  16. C Marth15,
  17. I Soumaoro16,
  18. S Jain17 and
  19. B Slomovitz18
  1. 1Leuven Cancer Institute, Bgog and University Hospitals Leuven, Leuven, Belgium
  2. 2Massey Cancer Center, Virginia Commonwealth University, Department of Obstetrics and Gynecology, Richmond, USA
  3. 3Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens and CHRU Jean Minjoz, Oncology, Besançon, France
  4. 4Rigshospitalet, University Hospital of Copenhagen, and Nordic Society of Gynaecological Oncology Clinical Trial Unit (NSGO-CTU), Centre For Cancer and Organ Diseases, Copenhagen, Denmark
  5. 5Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Clínica Universidad de Navarra, Department of Medical Oncology, Madrid, Spain
  6. 6Central and Eastern European Gynecologic Oncology Group (CEEGOG), General University Hospital, Charles University, Department of Obstetrics and Gynecology and First Faculty of Medicine, Prague, Czech Republic
  7. 7Arizona Oncology (US Oncology Network), Gynecologic Oncology, Obstetrics and Gynecology, Phoenix, USA
  8. 8AGO and University Medical Center Hamburg-Eppendorf, Department of Gynecology, Hamburg, Germany
  9. 9The National Cancer Research Institute and The Royal Marsden NHS Foundation Trust, Gynaecology Unit, London, UK
  10. 10Amsterdam University Medical Centers, Department of Medical Oncology, Amsterdam, Netherlands
  11. 11University of Milan-Bicocca, European Institute of Oncology, IRCCS and Mario Negri Gynecologic Oncology Group, Gynecologic Oncology Program, Milan, Italy
  12. 12Multicentre Italian Trials in Ovarian Cancer and Gynaecological Malignancies Group (MITO) and Scientific Directorate and Department of Women and Child Health, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Gynaecology Oncology Unit, Rome, Italy
  13. 13Cancer Trials Ireland, Gynaecology, Dublin, Ireland
  14. 14US Oncology Research, Department of Gynecologic Oncology, The Woodlands, USA
  15. 15Arbeitsgemeinschaft Gynäkologische Onkologie Austria (AGO-Austria), Medizinische Universität Innsbruck, Department of Obstetrics and Gynecology, Innsbruck, Austria
  16. 16Genmab US, Inc., Oncology, Plainsboro, USA
  17. 17Seagen Inc., Late Stage Development, Bothell, USA
  18. 18Broward Health, Department of Gynecologic Oncology, Fort Lauderdale, USA


Objectives Doublet chemotherapy (paclitaxel plus either platinum or topotecan) with bevacizumab (if eligible) is recommended for first–line treatment of recurrent/metastatic cervical cancer (r/mCC; Tewari 2014). In the second–line setting, there are limited data for available treatment options. Tisotumab vedotin (TV) is an investigational antibody–drug conjugate directed to tissue factor. In the phase 2 pivotal trial (innovaTV 204/ENGOT-cx6/GOG-3023) in r/mCC patients with disease progression on or after chemotherapy, TV demonstrated clinically meaningful and durable activity (objective response rate [ORR]: 24%; median duration of response [DOR]: 8.3 months) with a manageable and tolerable safety profile. Most adverse events associated with TV were mild to moderate. These findings support further investigation of TV in patients with r/mCC who progress on first–line treatment.

Methods innovaTV 301/ENGOT-cx12/GOG-3057 (NCT04697628) is a global, randomized, open-label, phase 3 trial evaluating efficacy and safety of TV in patients with previously treated r/mCC. Eligible patients are ≥18 years, have r/mCC, and have progressed after 1–2 prior lines of therapy (either standard of care systemic chemotherapy doublet or platinum-based therapy with bevacizumab, if eligible). Approximately 482 patients will be randomized 1:1 to receive 21–day cycles of TV (2.0 mg/kg IV once every 3 weeks) or investigator’s choice of chemotherapy: topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed. The primary endpoint is overall survival. Key secondary endpoints are progression-free survival, ORR, time to response, DOR, safety, and quality of life outcomes. The study is enrolling and will have sites in the USA, Europe, Japan, Latin America, Taiwan, Singapore, and South Korea.

Results Not applicable.

Conclusions Not applicable.

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