eligibility_summary
Eligibility: UC, blood for intismeran autogene and ctDNA, FFPE tissue, ECOG 0-2. Adjuvant: MIUC with high-risk pathology after resection, cisplatin-ineligible if no prior neoadjuvant cisplatin. Perioperative: MIBC, eligible and agrees to RC+PLND, cisplatin-ineligible. Exclusions: live vaccine <30d, malignancy ≤3y, pneumonitis/ILD, active infection, HBV/HCV, prior therapies per cohort, severe hypersensitivity to intismeran autogene, pembrolizumab, or EV, neuropathy, keratitis/corneal ulcers.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1/2 trial in high-risk muscle-invasive urothelial carcinoma. Interventions: 1) Intismeran autogene (V940, mRNA‑4157) — a personalized mRNA cancer vaccine (biologic) encoding patient-specific tumor proteins to elicit tumor‑specific T‑cell responses, 2) Pembrolizumab (MK‑3475) — anti‑PD‑1 monoclonal antibody immune checkpoint inhibitor restoring T‑cell activity, 3) Enfortumab vedotin (PADCEV) — antibody‑drug conjugate that binds a tumor cell‑surface protein and delivers a cytotoxic payload, 4) Surgery (radical cystectomy + pelvic lymph node dissection). Targets/pathways: neoantigen‑specific CD8+/CD4+ T cells, PD‑1/PD‑L1/PD‑L2 checkpoint axis on T cells/tumor, urothelial carcinoma cells expressing the ADC’s target. Design: adjuvant V940+pembrolizumab vs placebo+pembrolizumab, perioperative pembrolizumab+V940+EV plus surgery.