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
ClinicalTrials.gov Identifier: NCT04223856
Principal Investigator: Victor Ricardo Adorno Febles.


If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.