Last updated on October 2018

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Brief description of study

The purpose of this study is to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy.

This study will also compare progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy.

In addition, this study will evaluate the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assess the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

Detailed Study Description

Participants considered an adult according to local regulation at the time of obtaining informed consent may participate in the study.

Clinical Study Identifier: NCT03474107

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Astellas Pharma Global Development

Queens Medical Associates
Fresh Meadows, NY United States
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Astellas Pharma Global Development

Long Island Jewish Medical Center
Lake Success, NY United States
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