Enfortumab Vedotin vs. chemotherapy in advanced or metatstatic urothel
Research type
Research Study
Full title
An Open-Label, Randomised Phase 3 Study to Evaluate Enfortumab Vedotin vs. Chemotherapy in Subjects with Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
IRAS ID
246006
Contact name
Ariane Moseleit
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2017-003344-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 7 days
Research summary
The main purpose of this study is to determine if a medicine called enfortumab vedotin (EV) is more effective than, safe and comparable to the following standard chemotherapies: (docetaxel, paclitaxel, or vinflunine) in patients with urothelial cancer who have received previous standard therapies. Standard chemotherapy in this setting is unclear. Three drugs- docetaxel, vinflunine and paclitaxel are used interchangeably and it will be up to the study doctor to decide which of these is the best treatment option for the patient.
Urothelial cancer is a cancer of the urinary system. The urothelium ist the lining of the bladder, renal pelvis, ureter or urethra. The study is directed at patients who were previously treated with chemotherapy containing a platinum (cisplatin or carboplatin) as well as a kind of anticancer drug called an immune checkpoint inhibitor (CPI) and whose cancer has spread to nearby tissues or to other areas of the body.
Enfortumab vedotin is an experimental drug that is being studied to treat urothelial cancer. It has not been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA) and/or any other regulatory authorities for approval for the treatment of any disease or type of cancer.
Participants will be randomly assigned in a 1:1 ratio to one of the following treatment groups:
A) Enfortumab vedotin
B) either docetaxel, paclitaxel or vinflunine (as decided by the study doctor)Approximately 550 participants will participate in this study at approximately 150 research centres globally. The Sponsor of the study is Astellas Pharma Global Development, Inc.
REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/1120
Date of REC Opinion
9 Jul 2018
REC opinion
Favourable Opinion