Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Summary

This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

Timeline

Start

2021-02-22

Primary completion

2023-07-24

Completion

2026-01-15

Publications

• Yonemori K, Nishio S, Suzuki S, Hasegawa K, Yunokawa M, Yamaguchi S, Okamoto A, Nakamura K, Kamiura S, Fujiwara K, Katsumata N, Kobayashi H, Usami T, Mochizuki A, Takehara K, Whalley E, Noguchi H, Soumaoro I, Slomovitz B, Vergote I. Tisotumab vedotin in Japanese patients with recurrent or metastatic cervical cancer: results from the innovaTV 301/ENGOT-cx12/GOG-3057 trial. Int J Gynecol Cancer. 2026 Apr;36(4):104450. doi: 10.1016/j.ijgc.2025.104450. Epub 2025 Dec 31.
• Vergote I, Gonzalez-Martin A, Fujiwara K, Kalbacher E, Bagameri A, Ghamande S, Lee JY, Banerjee S, Maluf FC, Lorusso D, Yonemori K, Van Nieuwenhuysen E, Manso L, Woelber L, Westermann A, Covens A, Hasegawa K, Kim BG, Raimondo M, Bjurberg M, Cruz FM, Angelergues A, Cibula D, Barraclough L, Oaknin A, Gennigens C, Nicacio L, Teng MSL, Whalley E, Soumaoro I, Slomovitz BM; innovaTV 301/ENGOT-cx12/GOG-3057 Collaborators. Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer. N Engl J Med. 2024 Jul 4;391(1):44-55. doi: 10.1056/NEJMoa2313811.

Drugs

Indications