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
A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer (EV-201)
Sponsor: Seattle Genetics, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAR9129
U.S. Govt. ID: NCT03219333
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: This clinical trial is for patients who have cancer of the urinary system (urothelial cancer, including cancer of the bladder, renal pelvis, ureter or urethra) that has spread to nearby tissues or to other areas of the body who have already been treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). This clinical trial uses an experimental drug, which has not been approved by the Food and Drug Administration (FDA) for sale in the United States to treat your disease. The experimental drug in this clinical trial is called enfortumab vedotin. We want to find out if enfortumab vedotin will treat urothelial cancer in patients who have already been treated with a CPI drug. We also want to find out about the side effects of the drug.
This study is closed
Mark Stein, MD
Do You Qualify?
Are you 18 years of age or older? Yes No
Do you have a diagnosis of cancer of the bladder, renal pelvis, ureter, or urethra (urothelial carcinoma)? Yes No
Have you previously received prior treatment with a checkpoint inhibitor for locally advanced or metastatic urothelial cancer? Yes No
Has your disease progressed or did your urothelial cancer come back during or following receipt of your most recent therapy? Yes No
You may be eligible for this study

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