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Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma

Urothelial Carcinoma Clinical Trial

Official title:
A Pilot Trial of Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma

Clinical Trial Summary

This is a non-randomized two arm open-label phase 2 pilot study in adult subjects with locally advanced or metastatic urothelial cancer. The study will investigate an alternative administration schedule of EV given as monotherapy and in combination with pembrolizumab.

Clinical Trial Description

This is a non-randomized two arm open-label phase 2 pilot study in adult subjects with locally advanced or metastatic urothelial cancer. The study will investigate an alternative administration schedule of EV given as monotherapy and in combination with pembrolizumab. Approximately 50 patients will be enrolled to the main EV monotherapy cohort who are scheduled to receive EV as standard of care. Additionally, an exploratory arm will enroll 20 patients with metastatic urothelial cancer who are scheduled to receive EV in combination with pembrolizumab as standard of care. All subjects will have histologically and radiographically confirmed locally advanced or metastatic urothelial carcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and meet baseline laboratory data as outlined in the section 4.1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05923190
Study type Interventional
Source Fox Chase Cancer Center
Contact Ryan Romasko
Phone 2678388380
Email ryan.romasko@fccc.edu
Status Recruiting
Phase Phase 2
Start date June 14, 2023
Completion date July 1, 2029
View Details
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