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
Outcome
Met primary endpoint
registry analysis (superiority test); Tisotumab Vedotin vs Chemotherapy; p = 0.0038; Cox Proportional Hazard 0.70 (95% CI 0.54 to 0.89) NCT04697628 ↗
paper The median overall survival was significantly longer in the tisotumab vedotin group than in the chemotherapy group PMID 38959480 ↗
release “innovaTV 301 confirmatory trial of tisotumab vedotin for the treatment of recurrent or metastatic cervical cancer met its primary endpoint of improved overall survival (OS)” genmab.com ↗
release “The innovaTV 301 study met its primary endpoint of OS” genmab.com ↗
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Irinotecan | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Irinotecan | Small molecule | 125 mg/m2 | Intravenous |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Tisotumab Vedotin | Other / unclassified | 2 mg/kg | — |
| Comparator | Topotecan | Small molecule | 1 mg/m2 | Intravenous |
| Comparator | Topotecan | Small molecule | 1.25 mg/m2 | Intravenous |
| Comparator | Vinorelbine | Small molecule | 30 mg/m2 | Intravenous |