Primary Outcomes:

Primary Outcome 1 - Measure: Event free survival (Arm A compared to Arm C)

Primary Outcome 1 - Time Frame: Randomization up to 55 months

Primary Outcome 2 - Measure: Event free survival (Arm B compared to Arm C)

Primary Outcome 2 - Time Frame: Randomization up to 55 months

Condition:

• Non-muscle Invasive Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Histological confirmed diagnosis of high risk non-muscle invasive transitional cell
carcinoma (TCC) of the urothelium of the urinary bladder (tumors of mixed
transitional/non-transitional cell histology are allowed, but TCC must be the
predominant histology)

- Complete resection of all Ta/T1 papillary disease (including participants with
concurrent CIS), with most recent TURBT occurring within 12 weeks prior to
randomization. A second TURBT must have been performed if indicated according to the
current locally applicable guidelines, ie, American Urological Association, European
Association of Urology

Exclusion Criteria:

- Evidence of muscle-invasive, locally advanced or metastatic urothelial cancer or
concurrent extravesical, non-muscle invasive TCC of the urothelium

- Intravesical BCG therapy within 2 years prior to randomization. Prior intravesical
chemotherapy for NMIBC is allowed

- Prior immunotherapy with anti PD-1, anti PD-L1, anti PD-L2, or anti cytotoxic
T-lymphocyte-associated antigen-4 (CTLA-4) antibody

- Prior treatment with immunostimulatory agents including interleukin (IL)-2, IL-15,
interferon (INF)

- Prior radiation therapy to the bladder
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No