NCT05014139

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.

Detailed description

The study will be comprised of 2 parts. The first part (dose escalation) will find the highest dose of enfortumab vedotin that does not cause unacceptable side effects in participants. The second part (dose expansion) will use the dose found in the first part to test how well the drug works. All participants will receive enfortumab vedotin. Treatment on the study will occur during the induction and maintenance phases, and participants will enter a follow-up period after completion of the maintenance phase.

Conditions

• Urinary Bladder Neoplasms
• Carcinoma in Situ
• Carcinoma Transitional Cell
• Non-muscle Invasive Bladder Cancer
• NMIBC

Interventions

Type	Name	Description
DRUG	Enfortumab vedotin	Given into the bladder (intravesically)

Timeline

• Start date: 2021-12-07
• Primary completion: 2025-09-22
• Completion: 2025-09-22
• First posted: 2021-08-20
• Last updated: 2025-11-20

Locations

32 sites across 6 countries: United States, Canada, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study