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40 InnovaTV 301/ENGOT-cx12/GOG-3057: tisotumab vedotin vs investigator’s choice chemo in second- or third-line recurrent or metastatic cervical cancer
  1. IB Vergote1,
  2. L Randall2,
  3. E Kalbacher3,
  4. K Madsen4,
  5. E Van Nieuwenhuysen1,
  6. A Gonzalez-Martin5,
  7. D Lorusso6,
  8. I Soumaoro7,
  9. S Jain8 and
  10. B Slomovitz9
  1. 1Belgium and Luxembourg Gynaecological Oncology Group, University of Leuven, Leuven Cancer Institute, Leuven, Belgium
  2. 2Virginia Commonwealth University, Massey Cancer Center, Richmond, VA, USA
  3. 3Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, CHRU Jean Minjoz, Besançon, France
  4. 4Rigshospitalet, University Hospital of Copenhagen, 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), Clínica Universidad de Navarra, Department of Medical Oncology, Madrid, Spain
  6. 6Multicentre 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, Rome, Italy
  7. 7Genmab US, Inc., Plainsboro, NJ, USA
  8. 8Seagen Inc., Bothell, WA, USA
  9. 9Broward Health, Fort Lauderdale, FL, USA


Introduction/Background*Doublet chemotherapy (paclitaxel plus either platinum or topotecan) with bevacizumab (if eligible) is recommended for first-line treatment of recurrent or 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 options.

Methodology 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 must be ≥18 years, have r/mCC, and have progressed after receiving 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.

Result(s)*Not applicable for trial in progress

Conclusion*Not applicable for trial in progress

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