Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
Public ClinicalTrials.gov record NCT06809140. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2 Trial of Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Urothelial Cancer of the Bladder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (clinical complete response) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., \>cTa disease) will undergo cystectomy.
Study identification
- NCT ID
- NCT06809140
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 6, 2025
- Primary completion
- Oct 31, 2027
- Completion
- Oct 31, 2029
- Last update posted
- Aug 4, 2026
2025 – 2029
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | Recruiting |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Recruiting |
| Columbia University Irving Medical Center | New York | New York | 10032 | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06809140, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2026 · Synced Sep 17, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06809140 live on ClinicalTrials.gov.