Enfortumab Vedotin and Stereotactic Radiation for Localized Bladder Cancer

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 ID

NCT06394570

Phase

PHASE1 / PHASE2

Sponsor

University of Texas Southwestern Medical Center

Status

RECRUITING

Cancer Type

Bladder Cancer

Interventions

Enfortumab vedotin

Locations (sample)

Dallas, Texas, United States|32.78306,-96.80667

Key Eligibility Criteria

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.
Mixed cell types with variant histologies (including squamous, plasmacytoid, adenocarcinoma, sarcomatoid, micropapillary, nested, and lipid cell va…
Age \>=18.

For full eligibility, visit ClinicalTrials.gov.

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