eligibility_summary
Adults (≥18) with cT2–T4a N0M0 urothelial bladder cancer scheduled for radical cystectomy, variants allowed if any urothelial present, exclude small cell/neuroendocrine. Cisplatin‑ineligible (Galsky), ECOG 0–1, adequate marrow/liver, no dialysis. Use contraception, consent required. Exclude prior systemic bladder therapy or pelvic RT (intravesical OK), ≥Grade 2 neuropathy, other trials, EV allergy, uncontrolled illness, pregnancy/nursing.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: STAR-EV (NCT06394570) tests neoadjuvant enfortumab vedotin (EV) plus stereotactic radiotherapy (RT) before cystectomy in cisplatin-ineligible muscle-invasive bladder cancer. Interventions: - Enfortumab vedotin (PADCEV): an antibody–drug conjugate (human IgG1 mAb) targeting Nectin-4, linked to the microtubule toxin MMAE. Mechanism: binds Nectin-4 on urothelial tumor cells → internalization → MMAE release → microtubule/mitotic spindle disruption and apoptosis, possible bystander and immunogenic effects. - Stereotactic body RT to the bladder (32.5 Gy in 5 fractions), given sequentially or concurrently with EV. Mechanism: induces DNA double-strand breaks and tumor cell death, may enhance immunogenicity and drug sensitivity. Targets/pathways: Nectin-4–expressing urothelial carcinoma cells, microtubules/mitosis, DNA damage response/repair pathways in bladder tumor cells.