NCT04223856

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 886 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

Detailed description

Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan. This study is being conducted to evaluate the combination of enfortumab vedotin + pembrolizumab versus standard of care gemcitabine + platinum-containing chemotherapy, in subjects with previously untreated locally advanced or metastatic urothelial cancer. Enfortumab vedotin may be administered for an unlimited number of cycles until a protocol defined reason for study discontinuation occurs. Pembrolizumab may be administered for a maximum of 35 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first. Cisplatin or carboplatin plus gemcitabine may be administered for a maximum of 6 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first.

Conditions

• Urothelial Cancer

Interventions

Type	Name	Description
DRUG	Enfortumab vedotin	Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle
DRUG	Pembrolizumab	IV infusion on Day 1 of every 3-week cycle
DRUG	Cisplatin	administered as IV infusion on Day 1 of each 3-week cycle
DRUG	Carboplatin	Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle
DRUG	Gemcitabine	IV infusion on Days 1 and 8 of every 3 week cycle

Timeline

• Start date: 2020-03-30
• Primary completion: 2023-08-08
• Completion: 2028-03-01
• First posted: 2020-01-10
• Last updated: 2025-06-13
• Results posted: 2024-09-27

Locations

260 sites across 25 countries: United States, Argentina, Australia, Belgium, Canada, China, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Netherlands, Poland, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study