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EV-201 for Advanced Bladder Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if enfortumab vedotin will work for patients with advanced urothelial cancer who have been previously treated with an immunotherapy.

What is the Condition Being Studied?

Advanced Bladder Cancer (Urothelial Cancer)

Who Can Participate in the Study?

Adult patients with advanced bladder cancer who have gotten an immunotherapy but have not gotten chemotherapy.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Have a screening visit that includes a blood draw, urine collection, eye exam, and imaging scans

Once you have completed the screening phase, you will:
- Have physical exams, blood tests, questions about your medications and side effect, and an imaging scan will be done every 8 weeks at your study visits
- Get the study drug enfortumab vedotin as an infusion in 28 day cycles.
-- You will get study drug on days 1, 8 and 15 of each cycle
-- Each cycle will require at least 3 visits to Duke

As long as you are not experiencing major side effects and the imaging scans show that your cancer is under control, you will continue to have study visits and get the study treatment.

After you finish all the study visits and have finished the study treatment, you will be contacted about every 3 months to see how you are doing and to see what other cancer therapies you may be on.

Study Details

Full Title
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
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00089691
NCT:NCT03219333
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698