Tisotumab Vedotin vs Chemo. in Recurrent, Metastatic Cervical Cancer
Research type
Research Study
Full title
A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator’s Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer
IRAS ID
294195
Contact name
Susana Banerjee
Contact email
Sponsor organisation
Seagen Inc.
Eudract number
2019-001655-39
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
135476, IND. ; ENGOT CX-12, ENGOT
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Tisotumab Vedotin (TV) is an antibody-drug conjugate (ADC) targeting tissue factor (TF), with previous clinical data demonstrating good results in treating of the cervical cancer. The purpose of this trial is to evaluate the efficacy of Tisotumab Vedotin compared to one of the following chemotherapy (Topocan, Vinorelbine, Gemcitabine, Irinotecan, Pemetrexed), in participants with recurrent, metastatic (spread into other parts of the body) cervical cancer, who have received 1 or 2 prior lines of systemic therapy for their disease treatment.
Patient will either receive Tisotumab Vedotin or one of the chemotherapy treatment available at their hospital, via intravenous infusion, every 21 days.
While on study treatment, subjects will be assessed for progression every 6 weeks for the first 30 weeks, and every 12 weeks thereafter. Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. After completion of study treatment and after occurrence
of disease progression, subjects in both arms of the study will continue to be followed for survival until study closure or withdrawal of consent.REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0329
Date of REC Opinion
14 Jun 2021
REC opinion
Further Information Favourable Opinion