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

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)