eligibility_summary
Adults ≥18 with high‑risk upper tract urothelial carcinoma, ECOG 0–1, tumor tissue available, adequate hematologic/renal/hepatic/coagulation (e.g., ANC ≥1500, Plt ≥100k, Hgb ≥9, CrCl ≥30), contraception required. Exclude: pregnancy, prior PD‑1/PD‑L1/CTLA‑4, recent systemic therapy/radiation/surgery, live vaccine, investigational agents, immunodeficiency/high‑dose steroids, other active cancer, CNS mets, autoimmune, pneumonitis, infection, uncontrolled HIV/HBV/HCV, transplant, prior enfortumab, severe allergy, life expectancy <12 wks, active keratitis/corneal ulcer, conditions impairing participation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm trial testing neoadjuvant pembrolizumab plus enfortumab vedotin before radical nephroureterectomy (RNU), followed by adjuvant pembrolizumab, in high-risk upper tract urothelial carcinoma. Drugs and mechanisms: 1) Pembrolizumab—humanized IgG4 anti–PD-1 monoclonal antibody (immune checkpoint inhibitor) that blocks the PD-1/PD-L1 pathway to restore antitumor cytotoxic T-cell activity. 2) Enfortumab vedotin—anti–nectin-4 antibody-drug conjugate that binds nectin-4 on urothelial tumor cells and delivers MMAE (vedotin), a microtubule-disrupting cytotoxin, inducing apoptosis. Targets: PD-1 on T cells (checkpoint axis), nectin-4–expressing urothelial cancer cells, and microtubule dynamics. RNU surgically removes residual tumor.