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

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 intravescial administration or intravesical surgical
manipulation (cystoscopy or biopsy)