Spots Global Cancer Trial Database for Pembrolizumab in Muscle-invasive Bladder Cancer
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Trial Identification
Brief Title: Pembrolizumab in Muscle-invasive Bladder Cancer
Official Title: Neoadjuvant Pembrolizumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing
Study ID: NCT05406713
Interventions
Study Description
Brief Summary: Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. A CT of the abdomen and pelvis may be performed if there are contraindications to MRI. Patients will also undergo a restaging cystoscopy and biopsies/TURBT as outlined in the protocol. Patients achieving a clinical complete response to treatment (defined in the protocol) will proceed with "maintenance" single agent pembrolizumab followed by surveillance. All other patients will proceed with standard of care local therapy as per their treating physicians followed by "adjuvant" pembrolizumab.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Contact Details
Name: Matthew D Galsky, MD
Affiliation: Icahn School of Medicine at Mount Sinai
Role: PRINCIPAL_INVESTIGATOR
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