A Phase III, Open-Label, Randomised, Multicentre, Global Study of Adjuvant Datopotamab Deruxtecan in Combination With Rilvegostomig in Participants With High-risk Muscle Invasive Urothelial Carcinoma (TROPION-Urothelial04).
Sponsor: AstraZeneca AB
Phase: 3
Disease: High-risk muscle-invasive urothelial carcinoma, Muscle-invasive bladder cancer, Upper tract urothelial carcinoma
EU trial number: 2025-525030-57-00
Population: Adults with histologically confirmed muscle-invasive urothelial carcinoma of the bladder, renal pelvis, or ureter who have high-risk residual pathological disease after R0 radical resection and no clinical or radiographic evidence of recurrence or metastasis. Eligible participants have pT3-pT4aN0 or pN+ disease without neoadjuvant therapy, or ypT2-ypT4a or ypN+ disease after neoadjuvant treatment, with ECOG performance status 0-1.
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