A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer

This study is for Indian adults in India who have cancer in the bladder lining (urothelial cancer). Their cancer is advanced or has spread to other parts of the body. Enfortumab vedotin is a treatment for this type of cancer. The main aim of the study is to confirm the safety of enfortumab vedotin in Indian adults with urothelial cancer. During the study, people will receive enfortumab vedotin. The study treatment will be given to people slowly through a tube into a vein. This is called an infusion. People will receive 3 separate infusions of enfortumab vedotin in each 28-day (4 weeks) treatment cycle. People visit their study clinic for health-checks several times during and after they receive enfortumab vedotin.

NCT Number	NCT06862219
Lead Sponsor	Astellas Pharma Global Development, Inc. Collaborators: Pfizer
Conditions	Metastatic Urothelial Carcinoma
Enrollment	100 participants
Start Date	2025-06-21
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-28