OncoMatch/Clinical Trials/NCT06394570
Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer
Is NCT06394570 recruiting? Yes, currently enrolling (May 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 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: prior therapy for non-muscle invasive bladder cancer >12 months prior to registration allowed; prior intra-vesical therapies allowed, including Bacillus Calmette-Guerin (BCG) for non-muscle invasive bladder cancer; prior chemotherapy for other cancers allowed if given >=1 year prior to study registration
No prior systemic therapy (except prior therapy for non-muscle invasive bladder cancer >12 prior to registration) for bladder cancer or prior pelvic radiotherapy. Prior intra-vesical therapies are allowed, including Bacillus Calmette-Guerin (BCG) for non-muscle invasive bladder cancer. Prior chemotherapy for other cancers is allowed if given >=1 year prior to study registration.
Cannot have received: pelvic radiotherapy
No prior systemic therapy ... or prior pelvic radiotherapy.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >=1500/mm3; Platelet count >=100x10^9/L; Hemoglobin ≥ 9 g/dL
Kidney function
Creatinine Clearance <60ml/min by standard institutional calculation method (cisplatin ineligibility); no end stage renal disease requiring dialysis allowed
Liver function
Serum bilirubin ≤ 1.5 × upper limit of normal (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: -Absolute neutrophil count (ANC) >=1500/mm3 * Platelet count >=100x10^9/L * Hemoglobin ≥ 9 g/dL •Hepatic: * Serum bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease * Alanine aminotransferase (ALT) and aspartate aminotransferase (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
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