eligibility_summary
Inclusion: ≥18, high‑grade UTUC, refuse/ineligible for RNU, no prior systemic therapy for advanced UC (except neoadj/adj >12 mo), N1≤2 cm ok, ECOG 0–2, labs ok, consent, contraception. Exclusion: prior enfortumab, PD‑(L)1 or other T‑cell agents, recent chemo/biologic/RT/surgery, uncontrolled diabetes, life expectancy <12 wks, neuropathy ≥G2, active infection incl HBV/HCV/HIV/TB, high‑dose steroids/active autoimmune, ILD/pneumonitis, prior transplant, live vaccine <30 d, severe drug allergy, active keratitis, other active malignancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm trial in high‑grade non‑metastatic upper tract urothelial cancer (UTUC) patients who decline/are ineligible for nephroureterectomy tests enfortumab vedotin plus pembrolizumab. Enfortumab vedotin (Padcev) is an antibody‑drug conjugate targeting Nectin‑4 on urothelial tumor cells, after binding and internalization it releases the microtubule toxin MMAE, disrupting tubulin polymerization, causing G2/M arrest and apoptosis. Pembrolizumab (Keytruda) is a humanized IgG4 monoclonal antibody that blocks PD‑1, preventing PD‑1/PD‑L1/PD‑L2 signaling to restore antitumor T‑cell activity. Key targets/pathways: Nectin‑4–positive urothelial cancer cells, microtubule cytoskeleton, PD‑1 immune checkpoint on activated T cells within the tumor microenvironment. Aim: achieve event‑free survival comparable to surgery while preserving renal unit. IV every 3 weeks until progression or intolerance.