Primary Outcomes:

Primary Outcome 1 - Measure: Overall Clinical Response (CR) Rate

Primary Outcome 1 - Time Frame: Up to 5 years

Condition:

• Urinary Bladder Neoplasms

Eligibility

Criteria:
Inclusion Criteria:

- Histologically confirmed diagnosis of high-risk, non-muscle invasive urothelial
carcinoma in situ (CIS; Tis), with or without papillary disease (T1, high-grade Ta)
within 12 months of completion of adequate Bacillus Calmette-Guerin (BCG) therapy.
Mixed histology tumours are allowed if urothelial differentiation (transitional cell
histology) is predominant (example, less than (<) 20 percent (%) variant histologic
subtype). However, the presence of neuroendocrine, micropapillary, signet ring cell,
plasmacytoid, or sarcomatoid features will make a participant ineligible. For
participants with lamina propria invasion (T1) on the screening biopsy/ transurethral
resection of bladder tumor (TURBT), muscularis propria must be present in order to
rule out Muscle Invasive Bladder Cancer (MIBC)

- Visible papillary disease must be fully resected (absent) prior to randomization
(residual CIS acceptable) and documented at screening cystoscopy

- Participants must be ineligible for or have elected not to undergo radical cystectomy

- BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as
a minimum of 5 of 6 doses of an induction course (adequate induction) plus 2 of 3
doses of a maintenance course, or 2 of 6 doses of a second induction course

- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

Exclusion Criteria:

- Histologically confirmed, muscle-invasive, locally advanced, nonresectable, or
metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV

- Concurrent extra-vesical (that is, urethra, ureter, or renal pelvis) non-muscle
invasive transitional cell carcinoma of the urothelium

- Participants with an active, known or suspected autoimmune disease. Participants with
autoimmune disorders not requiring systemic treatment (example, skin conditions such
as vitiligo, psoriasis, alopecia) or conditions requiring hormonal replacement
therapies such as type 1 diabetes mellitus or hypothyroidism are permitted to enroll

- Known active hepatitis B or C infection (for example, participants with history of
hepatitis C infection but normal hepatitis C virus polymerase chain reaction test and
participants with hepatitis B with positive hepatitis B surface antigen (HBsAg)
antibody are allowed)

- Prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-ligand 2 (L2)
agent, or with an agent directed to another co-inhibitory T-cell receptor
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No