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

Brief description of study

The purpose of the study is to evaluate the combination of enfortumab vedotin + pembrolizumab, with or without platinum-containing chemotherapy, versus standard of care gemcitabine + platinum-containing chemotherapy. We want to know if one treatment is better than another treatment for efficacy and safety. The study drug enfortumab vedotin is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.

Clinical Study Identifier: s19-01984 Identifier: NCT04223856

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