Clinical Trial Details

USOR 17005

A Single-arm, Open-label, Multicenter Study of Enfortumab Vedotin (ASG-22CE) for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Immune Checkpoint Inhibitor (CPI) Therapy

Purpose/Objective

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Full Trial Details: ClinicalTrials.gov

Condition: Urothelial Cancer
Study Type: Interventional
Phase: N/A
Study Start Date: 10/16/17
Study Completion Date: 11/2020

This study will examine the safety and anticancer activity of enfortumab vedotin given intravenously to patients with locally advanced or metastatic urothelial cancer who previously received a CPI and either previously received platinum-containing chemotherapy (Cohort 1) or are platinum-naïve and cisplatin-ineligible (Cohort 2). Patients who received platinum in the adjuvant/neoadjuvant setting and did not progress within 12 months of completion will be considered platinum-naïve. Approximately 100 patients are expected to be enrolled in each cohort. The primary goal of the study is to determine the confirmed ORR of enfortumab vedotin.

NCT Number

NCT03219333

Principal Investigator(s)

Nicholas Farrell, MD

Sponsor(s)

Astellas Pharma Global Development, Inc.

Participant Eligibility

• Age: 18 - No Maximum
• Gender: Male, Female