Study
| Phase 3, open-label, randomized trial (AMBASSADOR) |
| High-risk muscle-invasive urothelial carcinoma after radical surgery |
| Pembrolizumab (200 mg q3w for 1 yr) vs. observation |
Efficacy
| mDFS: 29.6 mos vs. 14.2 mos (pembrolizumab vs. observation) (HR: 0.73 [0.59-0.90], p=0.003) |
Safety
| Grade ≥3 AEs: 50.6% vs. 31.6% |
| Common AEs: Fatigue, pruritus, diarrhea, hypothyroidism |
N Engl J Med 2025;392:45-55
http://doi.org/10.1056/NEJMoa2401726
Reviewed by Ulas D. Bayraktar, MD on Mar 31, 2025
