This is a clinical trial studying the administration of NanoDoce as a direct injection to the bladder wall immediately after tumor resection and as an intravesical instillation. All participants will receive NanoDoce, and will be evaluated for safety and tolerability, as well as the potential effects of NanoDoce on urothelial carcinoma.
In this clinical trial, subjects with high-risk non-muscle invasive bladder cancer (NMIBC) or muscle invasive bladder cancer (MIBC), will receive NanoDoce. Subjects will be stratified into two treatment groups, Group 1 (NMIBC) and Group 2 (MIBC). All subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT), followed by an initial NanoDoce intravesical instillation. Once the TURBT resection site is healed (approximately 1 month), Group 1 (NMIBC) subjects will proceed to a 3-month Induction period (6 weekly NanoDoce intravesical instillations, followed by 6 weeks of rest). After the Induction period, following confirmation of non-recurrence, Group 1 subjects will proceed to a 3-month Maintenance period (3 weekly NanoDoce intravesical instillations, followed by 9 weeks of rest). After NanoDoce direct injection and the initial intravesical instillation, Group 2 subjects will proceed to institutional standard of care and will not receive Induction or Maintenance intravesical instillations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT)
All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.
Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.
BCG Oncology, PC
Phoenix, Arizona, United States
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions
Baltimore, Maryland, United States
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
UT Health San Antonio
San Antonio, Texas, United States
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.
Time frame: Up to End of Treatment (Month 6 for Group 1 and Group 2 Subset, and Day 45 for Group 2)
Recurrence Free Survival (RFS)
No evidence of tumor recurrence or disease progression
Time frame: At Months 6, 9, and 12
Disease Progression
Disease progression at Day 45 derived from cytology and biopsy assessments
Time frame: Day 45
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