eligibility_summary
Include: la/mUC confirmed (≥50% UC, no neuroendocrine), no prior systemic la/mUC therapy, prior neoadjuvant/adjuvant chemo ok, prior PD‑1/PD‑L1 in earlier stage ok if >12 mo, tumor tissue required. Exclude: other cancer unless disease‑free ≥3y, unstable CNS mets/leptomeningeal, live vaccine <30d, investigational tx <4w, immunosuppression, active autoimmune (past 2y), uncontrolled diabetes, pneumonitis, active infection (incl HIV/HBV/HCV), major surgery <4w, allogeneic transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1/2 umbrella trial in first-line metastatic urothelial carcinoma testing: 1) Coformulated favezelimab/pembrolizumab + enfortumab vedotin (EV), 2) Coformulated vibostolimab/pembrolizumab + EV, vs 3) Pembrolizumab + EV. Drug types/mechanisms: Pembrolizumab—anti-PD-1 monoclonal antibody releasing T-cell inhibition. Favezelimab—anti-LAG-3 mAb enhancing T-cell activation. Vibostolimab—anti-TIGIT mAb blocking TIGIT/CD155 to augment T and NK cell responses. EV (Padcev)—antibody-drug conjugate targeting Nectin-4 that delivers MMAE, a microtubule-disrupting cytotoxin, to kill tumor cells. Targets: PD-1/PD-L1, LAG-3, TIGIT checkpoints on T cells (±NK cells for TIGIT), Nectin-4–expressing urothelial cancer cells. Note: The vibostolimab/pembrolizumab arm was discontinued and transitioned to pembrolizumab alone.