Actively Recruiting
Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer
Led by University of Texas Southwestern Medical Center · Updated on 2025-09-15
19
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
A
Astellas Pharma Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Urothelial carcinoma of the urinary bladder stage cT2-4a (AJCC 8th edition) N0M0 planned for radical cystectomy
- Mixed cell types with variant histologies allowed if urothelial histology present; small cell/neuroendocrine excluded
- Ineligibility for cisplatin-based chemotherapy based on physician assessment and Galsky criteria or patient refusal
- Age 18 years or older
- ECOG performance status 0-1
- Adequate organ and marrow function: ANC 215000/mm3, Platelets 21100x10^9/L, Hemoglobin 219 g/dL
- Hepatic function: Serum bilirubin 211.5 x ULN (or 213 x ULN for Gilbert's disease), ALT and AST 212.5 x ULN
- No end stage renal disease requiring dialysis
- Men and women of child-bearing potential must agree to use contraception during study and for 3 months after
- Female of child-bearing potential defined by no hysterectomy or bilateral oophorectomy and not postmenopausal for 12 months
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior systemic therapy for bladder cancer within 12 months, except for non-muscle invasive bladder cancer
- Prior pelvic radiotherapy
- Baseline grade 2 or higher sensory or motor neuropathy
- Receiving other investigational cancer treatments
- History of allergic reactions to enfortumab vedotin or similar compounds
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Pregnant or nursing women
AI-Screening
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Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
T
Tian Zhang, MD, MHS
CONTACT
A
Amy Rowell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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