36
Participants
Start Date
April 2, 2019
Primary Completion Date
November 2, 2021
Study Completion Date
November 2, 2021
NanoDoce (direct injection)
Subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT)
NanoDoce (intravesical instillation) - Visit 2 Instillation
All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
Institutional Standard of Care
Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.
NanoDoce (intravesical instillation) - Induction and Maintenance Instillations
Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.
Columbia University Herbert Irving Comprehensive Cancer Center, New York
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore
Carolina Urologic Research Center, Myrtle Beach
UT Health San Antonio, San Antonio
BCG Oncology, PC, Phoenix
Lead Sponsor
US Biotest, Inc.
INDUSTRY
NanOlogy, LLC
INDUSTRY