eligibility_summary
Adults (≥18) with measurable locally advanced/metastatic urothelial carcinoma planned for EV or EV+pembro, ECOG 0–2, prior systemic therapy ≥14 d, archival tumor tissue if available, adequate counts/organ function (CrCl>20, AST/ALT<2.5×ULN, <3.5× with liver mets). Exclude: prior MMAE ADCs, ≥G2 neuropathy, uncontrolled DM, uncontrolled CNS mets, major illness/infection, ILD/pneumonitis, prior allogeneic transplant, TB, pregnancy/breastfeeding. EV+pembro: prior IO ok unless severe irAE, active autoimmune disease or >20 mg steroids excluded.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05923190 tests schedule de-escalation of enfortumab vedotin (EV) alone or with pembrolizumab in metastatic/locally advanced urothelial carcinoma. EV is an antibody–drug conjugate (ADC): a Nectin‑4–targeting monoclonal antibody delivers the cytotoxic payload MMAE (a microtubule inhibitor), causing internalization, microtubule disruption, and tumor cell death, it targets Nectin‑4–expressing urothelial cancer cells and the microtubule pathway. Pembrolizumab is an anti–PD‑1 monoclonal antibody (immune checkpoint inhibitor) that blocks the PD‑1/PD‑L1 pathway to reinvigorate cytotoxic T cells. Thus, the trial targets Nectin‑4+ tumor cells and the microtubule apparatus (EV) and the PD‑1 checkpoint on T lymphocytes (pembrolizumab).