First Line Comparative Study of EN3348 (MCC) vs BCG in NMIBC

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double-blind, Multi-center Study Comparing MCC to BCG as First Line Immunotherapy in Patients With Non-muscle Invasive (Superficial) Bladder Cancer at High Risk of Recurrence or Progression

Conditions
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Bladder Cancer

Intervention / Treatment
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* Biological: Mycobacterial Cell-Wall DNA Complex
* Biological: Bacillus Calmette-Guerin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCC<br>Intravesical Administration of Mycobacterial Cell-Wall DNA Complex | Biological: Mycobacterial Cell-Wall DNA Complex<br>* 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.<br>|
| Active Comparator: BCG<br>Intravesical Administration of Bacillus Calmette-Guerin | Biological: Bacillus Calmette-Guerin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival rate at 2 years |  | Month 24 | 
| Frequency, severity, and nature of drug-related AEs |  | Baseline through 24 Months | 
| 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 | 
| Frequency, severity and nature of all AEs |  | Baseline through 24 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-muscle invasive bladder cancer, superficial bladder cancer