Phase 2 Study to Evaluate Enfortumab Vedotin plus Pembrolizumab in MIBC for bladder preservation
Research type
Research Study
Full title
An Open-label, Single-Arm, Phase 2 Study to Evaluate Enfortumab Vedotin plus Pembrolizumab for Bladder Preservation in Participants with Muscle-invasive Bladder Cancer (EV-209)
IRAS ID
1013839
Contact name
Taisa Paluch-Kassenberg
Contact email
Sponsor organisation
Astellas Pharma Global Development Inc.
Clinicaltrials.gov Identifier
Research summary
The goal of this study is to find out if enfortumab vedotin given with pembrolizumab helps treat people with muscle-invasive bladder cancer (MIBC) and keep their bladder by reducing the need to have surgery to remove it. Researchers will look at how enfortumab vedotin and pembrolizumab can act in the body.
The sponsor of this study is Astellas Pharma Global Development, Inc. Astellas is studying and developing enfortumab vedotin with a partner company, called Pfizer.
Approximately 240 people will take part in approximately 150 study sites globally. The anticipated duration of the study for each participant is approximately 48 months.
The study is made up of the following periods:
• Screening/baseline: for a maximum of 28 days prior to cycle 1 day 1
• Treatment period: beginning at cycle 1 day 1 and subsequent cycles until cycle 17
• Follow-up period: beginning after the participant discontinues the study treatment
o 30-day safety follow-up: 30 days from last dose
o Post treatment follow-up: every 12 weeks
o Survival follow-up: every 12 weeksThe study will involve the following: blood and urine tests, tumour biopsies, physical examinations, vital signs, participant interviews, disease imaging using MRI/CTs, cystoscopy/transurethral resection of bladder tumour (TURBT), ECGs, eye exams and study drug infusions.
REC name
East of England - Essex Research Ethics Committee
REC reference
26/EE/0117
Date of REC Opinion
3 Jun 2026
REC opinion
Further Information Favourable Opinion