Spots Global Cancer Trial Database for A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
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Trial Identification
Brief Title: A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
Official Title: A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
Study ID: NCT05014139
Interventions
Study Description
Brief Summary: This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). This study will also evaluate what the side effects are and if the drug works to treat NMIBC. A side effect is anything a drug does to your body besides treating your disease. In this study enfortumab vedotin will be put into the bladder using a catheter. A catheter is a thin tube that can be put into your bladder.
Detailed Description: The study will be comprised of 2 parts. The first part (dose escalation) will find the highest dose of enfortumab vedotin that does not cause unacceptable side effects in participants. The second part (dose expansion) will use the dose found in the first part to test how well the drug works. All participants will receive enfortumab vedotin. Treatment on the study will occur during the induction and maintenance phases, and participants will enter a follow-up period after completion of the maintenance phase.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic, Scottsdale, Arizona, United States
UCLA Department of Medicine - Hematology & Oncology, Los Angeles, California, United States
University of California, Irvine, Orange, California, United States
University of California at San Francisco, San Francisco, California, United States
Northwestern University-Feinberg School of Medicine, Chicago, Illinois, United States
Markey Cancer Center / University of Kentucky, Lexington, Kentucky, United States
Johns Hopkins Medical Center, Baltimore, Maryland, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
James Cancer Hospital / Ohio State University, Columbus, Ohio, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Erlanger Oncology and Hematology, Chattanooga, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
MD Anderson, Houston, Texas, United States
Urology San Antonio, San Antonio, Texas, United States
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
Site CA11001, Toronto, Ontario, Canada
Site FR33002, Lyon, , France
Site FR33001, Paris, , France
Site DE49001, Goettingen, , Germany
Site DE49002, Tübingen, , Germany
Site ES34001, Barcelona, , Spain
Site ES34004, Barcelona, , Spain
Site ES34003, Barcelona, , Spain
Site ES34002, Madrid, , Spain
Site UK44002, London, , United Kingdom
Contact Details
Name: Janet Trowbridge, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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