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NCT06394570Not yet recruiting

Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer

Stereotactic Treatment With neoAdjuvant Radiotherapy and Enfortumab Vedotin: a Phase I/II Study With Safety Lead-In for Localized, Cisplatin Ineligible, Muscle Invasive Bladder Cancer (STAR-EV)
University of Texas Southwestern Medical CenterPhase 1/2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Bladder Cancer
Drug/Device/Intervention
Enfortumab vedotin
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
University of Texas Southwestern Medical Center
Timeline & enrollment
Phase
Phase 1/2
Start date
Jul 01, 2024
End date
Jul 01, 2027
Enrollment
19 participants
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
Malignant neoplasm of bladderMalignant neoplasm: Bladder, unspecifiedMalignant neoplasm: Dome of bladderMalignant neoplasm: Overlapping lesion of bladderMalignant neoplasm: Lateral wall of bladder
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06394570
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.