A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients

Contact:

NCT Number:

Protocol:

AAAV0553

Study Status:

Active/Enrolling

Population:

Adult

Phase:

III

The purpose of this study is to learn more about if the combination of medications not approved by the Food and Drug Administration (FDA), called durvalumab, tremelimumab and enfortumab vedotin (EV) given intravenously before and after surgery will work and be safe to treat muscle invasive bladder cancer (This is a cancer that spreads into the detrusor muscle of the bladder. The detrusor muscle is the thick muscle deep in the bladder wall) in patients not eligible or who do not want to receive a type of platinum containing chemotherapy (cisplatin), and also to better understand the studied disease and associated health problems.

Are you Eligible? (Inclusion Criteria)

  • Participant must be ≥ 18 years at the time of screening - Participants with histologically or cytologically documented muscle-invasive TCC (also known as UC) of the bladder.

Specialty Area(s)

Principal Investigator

Profile Headshot
  • Associate Program Director, Hematology & Oncology Fellowship Program

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032