EV-103 enfortumab vedotin alone or with other therapies for urothelial cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about whether the study drug (enfortumab vedotin (EV)) is safe and effective when taken by people with different types of urothelial cancer.

This study will also look at how long EV stays in your body, how your immune system reacts to EV, and how you feel while taking EV.

What is the Condition Being Studied?

Urothelial cancer (locally advanced, metastatic, or muscle-invasive)

Who Can Participate in the Study?

Adults who:
-Are ineligible for cisplatin or carboplatin
-Have not have received prior systemic treatment for the stage of disease you currently have

*People with locally advanced or metastatic cancer must have a tumor that can be measured on imaging scans
*People with muscle-invasive bladder cancer must have already had a partial cystectomy of the bladder.

Age Group

What is Involved?

If you choose to join this study, you will:
-Be assigned to a group depending on what type of urothelial cancer you have
-Get the study drug called enfortumab vedotin (EV), which is given through a needle in a vein in your arm
-Have an eye exam
-Have blood and urine tests
-Have a biopsy taken
-Complete imaging scans
-Complete questionnaires

*People with muscle-invasive bladder cancer will be given EV before and after a transurethral resection of bladder tumor (TURBT) procedure.
*People whose cancer is locally advanced or metastatic will be given either EV alone or EV in combination with pembrolizumab.

Study Details

Full Title
A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer
Principal Investigator
Christopher Hoimes
Protocol Number
IRB: PRO00106426
NCT: NCT03288545
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center