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NCT05406713 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab in Muscle-invasive Bladder Cancer
A Phase 2 study of Urothelial Carcinoma and Muscle-Invasive Bladder Carcinoma, sponsored by Matthew Galsky.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 4
- Study locations
NCT05406713: Active Phase 2 study of Urothelial Carcinoma and Muscle-Invasive Bladder Carcinoma, sponsored by Matthew Galsky.
NCT05406713 is a Phase 2 study of Urothelial Carcinoma and Muscle-Invasive Bladder Carcinoma that is active but no longer recruiting, run by Matthew Galsky. The registered enrollment target is 46 participants, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (81% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05406713, a Phase 2 study of Urothelial Carcinoma and Muscle-Invasive Bladder Carcinoma, is active but no longer recruiting, sponsored by Matthew Galsky.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 4
- Study locations
Study Summary
Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. A CT of the abdomen and pelvis may be performed if there are contraindications to MRI. Patients will also undergo a restaging cystoscopy and biopsies/TURBT as outlined in the protocol. Patients achieving a clinical complete response to treatment (defined in the protocol) will proceed with "maintenance" single agent pembrolizumab followed by surveillance. All other patients will proceed with standard of care local therapy as per their treating physicians followed by "adjuvant" pembrolizumab.
Primary Outcome
Estimate the clinical complete response rate defined as cT0 or cTa disease after pembrolizumab
Conditions Studied
Interventions
- DRUG Pembrolizumab
Study Locations (4)
California
- City of Hope - Duarte
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis
New Mexico
- University of New Mexico Comprehensive Cancer Center - Albuquerque
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
What the registry record for NCT05406713 still lists
NCT05406713 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (81% lower).
The record links to 3 conditions, with Urothelial Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT05406713 reports a single indexed study location in California, Indiana, New Mexico.
Frequently Asked Questions
What is clinical trial NCT05406713 about?
NCT05406713 is a clinical study titled "Pembrolizumab in Muscle-invasive Bladder Cancer". Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. A CT of the abdomen and pe...
What is the current status of trial NCT05406713?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2022-07-13. Estimated completion is 2028-01.
What conditions does trial NCT05406713 study?
This clinical trial studies the following conditions: Urothelial Carcinoma, Muscle-Invasive Bladder Carcinoma, Localized Cancer.
What interventions are being tested in trial NCT05406713?
The interventions under investigation include: Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT05406713?
This trial is sponsored by Matthew Galsky, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05406713 being conducted?
This trial has 4 study locations across California, Indiana, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05406713's enrollment target sits among peer trials
46 54th of 85 higher than 32 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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