EV and pembrolizumab in untreated metastatic urothelial cancer
Research type
Research Study
Full title
An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer
IRAS ID
281627
Contact name
Jemma Capuozzo
Contact email
Sponsor organisation
Seattle Genetics, Inc.
Eudract number
2019-004542-15
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
116360 , IND Number
Duration of Study in the UK
2 years, 5 months, 27 days
Research summary
Urothelial cancer is estimated to kill nearly 200,000 patients globally each year. Patients with metastatic urothelial cancer represent a population with significant unmet medical need, as the 5-year mortality rate exceeds 85%.
After the current standard first-line treatment for locally advanced and metastatic urothelial cancer most patients are not cured and long-term survival is poor.
The aim of this trial is to evaluate the efficacy and safety of the study drug enfortumab vedotin when combined with other drugs to treat patients with previously untreated locally advanced or metastatic urothelial cancer. The sponsor, Seattle Genetics, aims to find out if using the study drug with other cancer drugs works better or worse than the standard treatment for urothelial cancer. The Phase II data has shown promising results.
Approximately 1095 people will take part across 17 countries. There will be approximately 9 sites in the UK.
Participants will be randomised with equal chance to 1 of 3 treatment arms:
Group A will receive the study drug plus pembrolizumab.
Group B will receive gemcitabine plus either cisplatin or carboplatin (which is the standard of care).
Group C will receive the study drug plus pembrolizumab plus either cisplatin or carboplatin.
Group A can get pembrolizumab for up to about 2 years/35 cycles. There’s no limit on the length of time they could get the study drug.
Group B can get gemcitabine and either carboplatin or cisplatin for up to about 4 months/6 cycles.
Group C can get either carboplatin or cisplatin for up to about 4 months and pembrolizumab for up to about 2 years. There’s no limit on the length of time they could get the study drug.
All treatments will be given via IV infusion.REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/1157
Date of REC Opinion
14 Dec 2020
REC opinion
Further Information Favourable Opinion