NCT06862219

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

A Multicenter, Phase 4, Open-label, Single-arm, Safety Study of Enfortumab Vedotin in Adult Indian Participants With Previously Treated Locally Advanced or Metastatic Urothelial Cancer

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metastatic Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Enfortumab Vedotin	Intravenous Infusion

Timeline

• Start date: 2025-06-21
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-03-06
• Last updated: 2026-03-06

Locations

10 sites across 1 country: India

Regulatory

• FDA-regulated drug study