eligibility_summary
Eligible: ≥18, ECOG 0–1, metastatic/unresectable variant or non‑urothelial epithelial bladder cancer (predominant), measurable disease, tumor tissue/biopsy, adequate organ function, prior therapy allowed with ≥4‑wk washout, life expectancy >12 wks, negative pregnancy test/contraception, consent/compliance. Exclude: neuroendocrine or non‑epithelial tumors, prior EV or PD‑1/PD‑L1, recent therapy/investigational, CNS mets, uncontrolled DM, ≥G2 neuropathy, infection/steroids, other cancers, autoimmune/hep B/C/TB, ocular disease, allograft, serious cardiac disease, pregnancy/breastfeeding, allergy, uncontrolled illness.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm trial in locally advanced/metastatic bladder cancers of variant histology tests enfortumab vedotin plus pembrolizumab. Enfortumab vedotin (Padcev) is an antibody–drug conjugate: an anti–nectin‑4 monoclonal antibody linked to the cytotoxic payload MMAE (vedotin). It binds nectin‑4 on tumor cells, internalizes, and releases MMAE to disrupt microtubules and induce apoptosis. Pembrolizumab (Keytruda) is an immune checkpoint inhibitor: an anti–PD‑1 monoclonal antibody that blocks PD‑1 to restore antitumor T‑cell activity. Targets/pathways: nectin‑4–expressing bladder cancer cells, microtubule network via MMAE, PD‑1/PD‑L1 immune checkpoint on T cells and tumor/immune cells. Exploratory correlative endpoints assess peripheral T‑cell subsets, myeloid-derived suppressor cells, and inflammatory cytokines.