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An Open-Label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination with Pembrolizumab with or without Chemotherapy, versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together alone or with platinum chemotherapy to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.
Primary Objective: 1. To compare progression free survival (PFS) between experimental arms (enfortumab vedotin + pembrolizumab [Arm A] and enfortumab vedotin + pembrolizumab + cisplatin or carboplatin [Arm C]) and the control arm (gemcitabine + cisplatin or carboplatin [Arm B]) by blinded independent central review (BICR) 2. To compare overall survival (OS) between experimental arms (Arm A and Arm C) and the control arm (Arm B)
Enfortumab Vedotin (); Gemzar (gemcitabine); Paraplatin (carboplatin); Pembrolizumab (Keytruda); carboplatin (); cisplatin (); gemcitabine ()