Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC (NCT07663747) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC
Netherlands56 participantsStarted 2026-09-01
Plain-language summary
This is a Phase 2 clinical intervention trial to assess efficacy of induction EVP to spare the bladder in stage T2-4aN0-1 urothelial bladder cancer (UBC), using a response-adapted approach
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants who are at least 18 years of age on the day of signing informed consent.
. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
. Patients with histologically confirmed cT2-4aN0-1M0 urothelial bladder cancer, seeking an alternative to radical cystectomy and/or patients who are medically unfit for surgery.
. Archival tumor tissue sample or newly obtained TURB of the bladder tumor is available. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
. Have adequate organ function as defined in Table 3 below. Specimens must be collected within 14 days prior to the start of study intervention.
. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Exclusion criteria
. Previous pelvic irradiation
. Upper tract urothelial cancer
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Estimated 2-year bladder-intact event-free survival (BI-EFS) for the intention-to-treat population, measured from day 1 of treatment until the moment of analysis
Timeframe: From the first dose of study treatment up to 2 years of follow-up
. Extensive carcinoma in situ (CIS) of the bladder
. Bilateral hydronephrosis
. Previous intravenous systemic therapy for bladder cancer, including chemotherapy, checkpoint inhibition or antibody-drug conjugate.
. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
. Contra-indication to one of the study treatment components
. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.