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Enfortumab Vedotin and Stereotactic Radiation for Localized Bladder Cancer

Study acronym: STAR-EV
StatusRecruiting
PhasePhase 1/2
Started2024-09-10
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 26 months later Jul 1, 2026 → Sep 30, 2028
See other at-risk trials from University of Texas Southwestern Medical Center

Amendment history

2026-09-18
Primary completion pushed: 2026-07-01 → 2028-09-30
Completion pushed: 2027-07-01 → 2029-09-30
2025-09-11
Study Identification, Study Status, Eligibility, Contacts/Locations v4
Eligibility criteria+158 characters
[...] ition) N0M0 planned for radical cystectomy. Mixed cell types with variant histologies (including squamous, plasmacytoid, adenocarcinoma, sarcomatoid, micropapillary, nested, and lipid cell variants) are allowed as long as any urothelial histology is present (i.e. -not 100% variant histology). Small cell/neuroendocrine component is >50% AND no small cell/neuroendocrine or plasmacytoid/signet ring componentexcluded. Ineligibility for cisplatin-based chemotherapy based on tr [...]
Study sitescontacts updated at 1 of 1 site
2024-09-11
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-09-01→confirmed 2024-09-10
Study sites0→1
2024-07-31
Study Status v2
Start date2024-07-01→2024-09-01
2024-05-06
Study Status v1
Re-verified, no change to tracked fields
2024-04-27
Original filing
STAR-EV will evaluate the combination of enfortumab vedotin plus radiotherapy (RT) as neoadjuvant treatment for 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.
Trial Details
NCT Number NCT06394570
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: Astellas Pharma Inc
Conditions Bladder Cancer
Enrollment 19 participants
Start Date 2024-09-10
Primary Completion 2028-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-30