eligibility_summary
Eligibility: Patients treated with PADCEV Injection according to the approved local label. Exclusions: any PADCEV contraindication per local label, or receiving/planning to receive an investigational medicine during the observation period.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Observational, post‑marketing surveillance in South Korea of adults with locally advanced/metastatic urothelial cancer treated with PADCEV (enfortumab vedotin). Drug/intervention and mechanism: Enfortumab vedotin (PADCEV, ASG‑22CE) is an intravenous antibody‑drug conjugate (ADC): a monoclonal antibody targeting NECTIN‑4 linked to the cytotoxic payload monomethyl auristatin E (MMAE), a microtubule inhibitor. After binding NECTIN‑4 on tumor cells, the ADC is internalized, linker cleavage releases MMAE, disrupting tubulin, causing G2/M arrest and apoptosis, may also enable bystander killing and ADCC. Cells/pathways targeted: NECTIN‑4–expressing urothelial carcinoma cells, microtubule polymerization/cell‑cycle machinery. Purpose: Collect real‑world outcomes and adverse events up to ~48 weeks of routine PADCEV use, no comparator.