A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 550
Summary
- Conditions
- Bladder Cancer
- Ureteral Cancer
- Urothelial Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Participants considered an adult according to local regulation at the time of obtaining informed consent may participate in the study. Sites in Japan Only: In case that EV is approved for marketing in Japan, the study will continue as "Phase 4 post-marketing study" in accordance with Good Post-marke...
Participants considered an adult according to local regulation at the time of obtaining informed consent may participate in the study. Sites in Japan Only: In case that EV is approved for marketing in Japan, the study will continue as "Phase 4 post-marketing study" in accordance with Good Post-marketing Study Practice after marketing authorization based on the indication approved. In this case, "Study" in the protocol is read as "Post-marketing study."
Tracking Information
- NCT #
- NCT03474107
- Collaborators
- Seagen Inc.
- Investigators
- Study Director: Medical Director Astellas Pharma Global Development, Inc.
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