OncoMatch/Clinical Trials/NCT06394570
Enfortumab Vedotin and Stereotactic Radiation for Localized Bladder Cancer
Official title: Stereotactic Treatment With neoAdjuvant Radiotherapy and Enfortumab Vedotin: a Phase I/II Study With Safety Lead-In for Localized Bladder Cancer (STAR-EV)
Is NCT06394570 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies Enfortumab vedotin for bladder cancer.
Treatment: Enfortumab vedotin — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Urothelial Carcinoma
Disease stage
Grade: high grade (for cR1 staged patients)
Urothelial carcinoma of the urinary bladder stage cT1-4a (AJCC 8th edition) N0M0 planned for radical cystectomy. For cR1 staged patients, the patient must have high grade disease AND be appropriate for cystectomy.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy for bladder cancer
Exception: prior therapy for non-muscle invasive bladder cancer >12 months prior to registration
No prior systemic therapy (except prior therapy for non-muscle invasive bladder cancer >12 prior to registration) for bladder cancer
Cannot have received: pelvic radiotherapy
No prior ... prior pelvic radiotherapy
Cannot have received: chemotherapy for other cancers
Exception: if given >=1 year prior to study registration
Prior chemotherapy for other cancers is allowed if given >=1 year prior to study registration
Lab requirements
Blood counts
ANC ≥1500/mm3; Platelet count ≥100x10^9/L; Hemoglobin ≥ 9 g/dL
Kidney function
No end stage renal disease requiring dialysis allowed
Liver function
Serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN for subjects with Gilbert's disease; ALT and AST ≤ 2.5 × ULN
Adequate organ and marrow function as defined below: Hematologic: ANC ≥1500/mm3, Platelet count ≥100x10^9/L, Hemoglobin ≥ 9 g/dL; Hepatic: Serum bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN for subjects with Gilbert's disease, ALT and AST ≤ 2.5 × ULN; Renal: No end stage renal disease requiring dialysis allowed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UT Southwestern Medical Center · Dallas, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06394570 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy for bladder cancer, pelvic radiotherapy, chemotherapy for other cancers disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages