Bladder Cancer
Conditions
Keywords
non-muscle invasive bladder cancer, superficial bladder cancer
Brief summary
The purpose of this study is to compare the safety and efficacy of EN3348 (MCC) versus BCG as first line treatment in patients with non-muscle invasive bladder cancer that are at high risk for recurrence or progression.
Interventions
BIOLOGICALMycobacterial Cell-Wall DNA Complex
8 mg/50 mL (sterile WFI) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.
BIOLOGICALBacillus Calmette-Guerin
mg/50 mL (sterile saline) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.
Sponsors
Bioniche Life Sciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* histologically confirmed urothelial carcinoma of the bladder (high grade Ta or T1 papillary lesions, CIS) * histologically confirmed diagnosis within 42 days of study treatment * life expectancy of greater than 5 years * ECOG performance status of 2 or less * absence of urothelial carcinoma involving the upper urinary tract or prostatic urethra within 12 months from start of study treatment
Exclusion criteria
* current or previous history of muscle invasive bladder tumors (\>T2) * current or previous history of lymph node and/or distant metastases from bladder cancer * current evidence of squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the bladder * current systemic cancer therapy * previous immunotherapy for bladder cancer * previous intravesical chemotherapy treatment * contraindication to use BCG of known tolerance to BCG * history of malignancy of any organ system within the past 5 years (with the exception of basal cell or squamous cell carcinoma, stage T1 prostate cancer, carcinoma in situ of the cervix, colon polyps) * patients who cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy or biopsy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of disease-free survival (time to recurrence, progression or death) in all patients | Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24 |
| Percent of patients who due to study drug-related AEs experience 2 consecutive treatment delays or discontinue due to drug related AEs | Baseline through 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Duration of progression-free survival (time to progression or death) in all patients | Baseline, Month 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48 and 60 |
| Frequency, severity, and nature of drug-related SAEs | Baseline through 24 months |
| Number of treatment delays and their reason | Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24 |
| Disease-free survival rate at 2 years | Month 24 |
| Number of treatment discontinuations and their reason | Baseline through 24 months |
| Duration of Survival (time to death from any cause) in all patients | Baseline through month 60 |
| Frequency, severity and nature of all AEs | Baseline through 24 months |
| Frequency, severity, and nature of drug-related AEs | Baseline through 24 Months |
Countries
United States
Outcome results
None listed