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NCT05581589 · ClinicalTrials.gov registry record · Phase 2
Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer
A Phase 2 study of Muscle-Invasive Bladder Carcinoma and Stage II Bladder Cancer AJCC v8, sponsored by University of Washington.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05581589: Recruiting Phase 2 study of Muscle-Invasive Bladder Carcinoma and Stage II Bladder Cancer AJCC v8, sponsored by University of Washington.
NCT05581589 is a Phase 2 study of Muscle-Invasive Bladder Carcinoma and Stage II Bladder Cancer AJCC v8 that is actively recruiting participants, run by University of Washington. The registered enrollment target is 18 participants, below the 124-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05581589, a Phase 2 study of Muscle-Invasive Bladder Carcinoma and Stage II Bladder Cancer AJCC v8, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests whether sacituzumab govitecan given before radical cystectomy works in treating patients with non-urothelial bladder cancer. Sacituzumab govitecan contains a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan before radical cystectomy may make the surgery more effective in patients with muscle invasive bladder cancer.
Primary Outcome
Percentage of patients with no histologic evidence of tumor at time of cystectomy (ypT0N0)
Conditions Studied
Interventions
- PROCEDURE Lymphadenectomy
- BIOLOGICAL Sacituzumab Govitecan
- PROCEDURE Radical Cystectomy
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-06-15 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 2 |
What NCT05581589 shows while recruiting
NCT05581589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 124-participant average among 14 other Muscle-Invasive Bladder Carcinoma trials with a reported enrollment target (85% lower).
The record links to 3 conditions, with Muscle-Invasive Bladder Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Lymphadenectomy is the first listed.
NCT05581589 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT05581589 about?
NCT05581589 is a clinical study titled "Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer". This phase II trial tests whether sacituzumab govitecan given before radical cystectomy works in treating patients with non-urothelial bladder cancer. Sacituzumab govitecan contains a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of t...
What is the current status of trial NCT05581589?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2023-06-15. Estimated completion is 2027-04-30.
What conditions does trial NCT05581589 study?
This clinical trial studies the following conditions: Muscle-Invasive Bladder Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8.
What interventions are being tested in trial NCT05581589?
The interventions under investigation include: Lymphadenectomy (PROCEDURE), Sacituzumab Govitecan (BIOLOGICAL), Radical Cystectomy (PROCEDURE).
Who is sponsoring clinical trial NCT05581589?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05581589 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05581589's enrollment target sits among peer trials
18 15th of 14 the lowest of 14 other Muscle-Invasive Bladder Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscle-Invasive Bladder 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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