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Recruiting Phase 2 Interventional

Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer

ClinicalTrials.gov ID: NCT06809140

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.

ClinicalTrials.gov public records Last synced Sep 17, 2026, 2:42 PM EDT

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
Lead sponsor
Matthew Galsky
Other
Enrollment
75 participants

Conditions and interventions

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.

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