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

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

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.

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)