eligibility_summary
Eligible: adults treated with enfortumab vedotin at Hôpital Lyon Sud or Centre Léon Bérard, with ≥6 months of follow-up, who are willing and able to provide non-opposition consent for participation and use of medical data. Exclude: any medical, social, or psychiatric condition that impairs the patient’s capacity to give informed consent or agree to data use.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial type: Retrospective observational study of patients with metastatic urothelial carcinoma treated with enfortumab vedotin (EV), with data collection only (no assigned therapy). Drugs/interventions and mechanisms: • Enfortumab vedotin (ADC, monoclonal antibody–drug conjugate) targets Nectin‑4 on tumor cells, delivering a cytotoxic payload that kills Nectin‑4–expressing cells. • Some patients may have received pembrolizumab (anti‑PD‑1 immune checkpoint inhibitor) restoring T‑cell antitumor activity. Cells/pathways targeted: • Nectin‑4–positive urothelial cancer cells, physiologic Nectin‑4 on keratinocytes (implicated in cutaneous AEs such as bullous/TEN‑like reactions). • PD‑1/PD‑L1 pathway on T cells (with pembrolizumab co‑therapy). Aim: Determine whether drug‑related cutaneous adverse events during EV therapy associate with progression‑free survival.