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NCT06394570 · ClinicalTrials.gov registry record · Phase 1
Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer
A Phase 1 study of Bladder Cancer, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT06394570 is a Phase 1 study of Bladder Cancer that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 19 participants, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06394570, a Phase 1 study of Bladder Cancer, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
STAR-EV will evaluate the combination of enfortumab vedotin plus radiotherapy (RT) as neoadjuvant treatment for muscle invasive bladder cancer prior to radical cystectomy surgery. The study will use "dose escalation" to evaluate the safety and efficacy of study treatment at three dose regimens: Level 0: EV treatment followed by RT to the bladder Level 1: EV treatment with RT starting on Cycle 2, Day 15 Level 2: EV treatment with RT starting on Cycle 1, Day 15 Following completion of EV+RT neoadjuvant therapy, all subjects will undergo surgery as part of routine care.
Conditions Studied
Interventions
- DRUG Enfortumab vedotin
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2024-09-10 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06394570
The ClinicalTrials.gov registry entry for NCT06394570 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,754-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 1 intervention - of which Enfortumab vedotin is the first listed.
NCT06394570 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06394570 about?
NCT06394570 is a clinical study titled "Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer". STAR-EV will evaluate the combination of enfortumab vedotin plus radiotherapy (RT) as neoadjuvant treatment for muscle invasive bladder cancer prior to radical cystectomy surgery. The study will use "dose escalation" to evaluate the safety and efficacy of study treatment at three dose regimens: Lev...
What is the current status of trial NCT06394570?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2024-09-10. Estimated completion is 2027-07-01.
What conditions does trial NCT06394570 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT06394570?
The interventions under investigation include: Enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT06394570?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06394570 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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