Intravesical Enfortumab Vedotin in Non-Muscle Invasive Bladder Cancer
What is the Purpose of this Study?
If you choose to join this study, you will:
- Get a dose of the study drug once a week for 6 weeks, then monthly for nine months
- Have hysical xxams, blood draws, and give urine samples
- Have MRI or CT scans
- Have a cystoscopy
- Have a bladder biopsy
- Get a dose of the study drug once a week for 6 weeks, then monthly for nine months
- Have hysical xxams, blood draws, and give urine samples
- Have MRI or CT scans
- Have a cystoscopy
- Have a bladder biopsy
What is the Condition Being Studied?
Non-Muscle Invasive Bladder Cancer (NMIBC)
Who Can Participate in this Study?
Adults ages 18+ who:
- Are diagnosed with NMIBC
- Do not respond to Bacillus Calmette-Guerin (BCG) therapy
- Are ineligible for or do not want to have a radical cystectomy
- Have a working bladder and are able to "hold it" for at least one hour after the study drug is given
- Are not pregnant
For more information about who can join this study, please contact the study team at urologyresearch@duke.edu.
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to find out if an investigational drug called enfortumab vedotinin (the study drug) is a safe and effective treatment for NMIBC.
Study Details
Full Title
A study of intravesical enfortumab vedotin for treatment of patients with non-muscle invasive bladder cancer (NMIBC)
Principal Investigator
Contacts
Diane Pinder
Email: diane.pinder@duke.edu
Protocol Number
IRB:
PRO00108709
NCT:
NCT05014139
ClinicalTrials.gov
View on ClinicalTrials.gov