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Be Part of Research - Trial Details - Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Completed

Open to: FEMALE

Age: 18.0 - N/A

Medical Conditions

Cervical Cancer


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Feb 2021 Jul 2023

Publications

"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."; "38959480"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 2.0 mg/kg every 3 weeks (Q3W)

Intervention Arm Group : Tisotumab vedotin;

Intervention Type : DRUG
Intervention Description : 1 or 1.25 mg/m2 intravenous (IV) on Days 1 to 5, every 21 days

Intervention Arm Group : Chemotherapy;

Intervention Type : DRUG
Intervention Description : 30 mg/m2 IV on Days 1 and 8, every 21 days

Intervention Arm Group : Chemotherapy;

Intervention Type : DRUG
Intervention Description : 1000 mg/m2 IV on Days 1 and 8, every 21 days

Intervention Arm Group : Chemotherapy;

Intervention Type : DRUG
Intervention Description : 100 or 125 mg/m2 IV weekly for 28 days, every 42 days

Intervention Arm Group : Chemotherapy;

Intervention Type : DRUG
Intervention Description : 500 mg/m2 IV on Day 1, every 21 days

Intervention Arm Group : Chemotherapy;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden NHS Foundation Trust
    Sutton
    SM2 5PT
  • The Royal Marsden NHS Foundation Trust
    London
    SW3 6JJ
  • Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital
    Cambridge
    England
    CB2 0QQ
  • The Christie NHS Foundation Trust
    Manchester
    M20 4BX


The study is sponsored by Seagen, a wholly owned subsidiary of Pfizer and is in collaboration with Genmab.




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Read full details for Trial ID: NCT04697628
Last updated 05 February 2026

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