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NCT06809140 · ClinicalTrials.gov registry record · Phase 2
Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
A Phase 2 study of Muscle Invasive Bladder Urothelial Carcinoma, sponsored by Matthew Galsky.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 5
- Study locations
NCT06809140: Recruiting Phase 2 study of Muscle Invasive Bladder Urothelial Carcinoma, sponsored by Matthew Galsky.
NCT06809140 is a Phase 2 study of Muscle Invasive Bladder Urothelial Carcinoma that is actively recruiting participants, run by Matthew Galsky. The registered enrollment target is 47 participants, below the 606-participant average among 5 other Muscle Invasive Bladder Urothelial Carcinoma trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06809140, a Phase 2 study of Muscle Invasive Bladder Urothelial Carcinoma, is actively recruiting participants, sponsored by Matthew Galsky.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
Clinical complete response rate will be defined as cT0 or cTa (low grade) disease at the time of restaging after 3 cycles of induction enfortumab vedotin plus pembrolizumab
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Enfortumab vedotin
Study Locations (5)
New York
- Icahn School of Medicine at Mount Sinai - New York
- Columbia University Irving Medical Center - New York
California
- City of Hope - Duarte
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2025-04-07 |
| Est. Completion | 2029-11 |
| Phase | Phase 2 |
What NCT06809140 shows while recruiting
NCT06809140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 606-participant average among 5 other Muscle Invasive Bladder Urothelial Carcinoma trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Muscle Invasive Bladder Urothelial Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06809140 lists 5 locations in 4 states (New York, California, Indiana).
Frequently Asked Questions
What is clinical trial NCT06809140 about?
NCT06809140 is a clinical study titled "Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer". 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 ach...
What is the current status of trial NCT06809140?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2025-04-07. Estimated completion is 2029-11.
What conditions does trial NCT06809140 study?
This clinical trial studies the following conditions: Muscle Invasive Bladder Urothelial Carcinoma.
What interventions are being tested in trial NCT06809140?
The interventions under investigation include: Pembrolizumab (DRUG), Enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT06809140?
This trial is sponsored by Matthew Galsky, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06809140 being conducted?
This trial has 5 study locations across California, Indiana, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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