Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer - Trial NCT06394570
Access comprehensive clinical trial information for NCT06394570 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by University of Texas Southwestern Medical Center and is currently Not yet recruiting. The study focuses on Bladder Cancer. Target enrollment is 19 participants.
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Study Focus
Sponsor & Location
University of Texas Southwestern Medical Center
Timeline & Enrollment
Phase 1/2
Jul 01, 2024
Jul 01, 2027
Primary Outcome
Maximum Tolerated Dose (MTD) Regimen,Pathologic Complete response rate at radical cystectomy
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06394570
Non-Device Trial