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)