Summary
This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus
carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants
with 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 efficacy
and safety will be assessed, and the recommended Phase 3 dose (RP3D) will be identified
when the data allow sufficient assessment of activity, safety, and tolerability. The
Phase 3 part will start contingent upon the assessment in the Phase 2 part, taking into
consideration the totality of information.