TROPION-Urothelial03 (TU03)

Urogenital tumors
Urothelial carcinoma of the urinary bladder (incl. renal pelvis, ureter)
other systemic therapies
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd pluscarboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participantswith la/mUC who progressed during or after EV plus pembrolizumab combination treatment.This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacyand safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identifiedwhen the data allow sufficient assessment of activity, safety, and tolerability. ThePhase 3 part will start contingent upon the assessment in the Phase 2 part, taking intoconsideration the totality of information.
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd pluscarboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participantswith la/mUC who progressed during or after EV plus pembrolizumab combination treatment.This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacyand safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identifiedwhen the data allow sufficient assessment of activity, safety, and tolerability. ThePhase 3 part will start contingent upon the assessment in the Phase 2 part, taking intoconsideration the totality of information.