Actively Recruiting
Phase 4 Safety Study of Enfortumab Vedotin Given by Infusion to Indian Adults With Advanced or Metastatic Urothelial Cancer
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-05-28
100
Participants Needed
13
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating enfortumab vedotin, a treatment for advanced or metastatic urothelial cancer cancer of the bladder lining, in Indian adults. This phase 4, open-label study aims to confirm the safety of enfortumab vedotin in participants whose cancer has progressed after previous treatments including checkpoint inhibitors and platinum-containing chemotherapy. Participants will receive enfortumab vedotin through intravenous infusion on days 1, 8, and 15 of each 28-day treatment cycle. This single-arm study involves repeated cycles of treatment, with all participants receiving the same study drug. The infusion schedule and dosage are designed to monitor treatment safety and tolerability. Throughout the study, participants will visit the clinic multiple times for health assessments including monitoring of adverse events, laboratory tests, vital signs, and electrocardiograms. Researchers will evaluate safety outcomes up to 8 months and also assess cancer response up to 34 months. The study involves careful tracking of participant health and treatment effects during and after the infusion cycles.
CONDITIONS
Brief Title
A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer
Research Team
A
Astellas Pharma Global Development, Inc.
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
