Spots Global Cancer Trial Database for Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma

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Trial Identification

Brief Title: Enfortumab Vedotin Schedule De-escalation in Metastatic Urothelial Carcinoma

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

Study ID: NCT05923190

Conditions

Urothelial Carcinoma

Metastatic Urothelial Carcinoma

Locally Advanced Urothelial Carcinoma

Interventions

Enfortumab vedotin

Pembrolizumab

Study Description

Brief 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.

Detailed 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.