Primary Outcomes:

Primary Outcome 1 - Measure: Pathologic Complete Response (pCR) Rate

Primary Outcome 1 - Time Frame: Up to approximately 15 Weeks (Time of surgery)

Primary Outcome 2 - Measure: Event-Free Survival (EFS)

Primary Outcome 2 - Time Frame: Up to approximately 71 months

Condition:

• Urinary Bladder Cancer, Muscle-invasive

Eligibility

Criteria:
Inclusion Criteria:

- Have a histologically confirmed diagnosis of urothelial carcinoma (UC) / muscle
invasive bladder cancer (MIBC) (T2-T4aN0M0 or T1-T4aN1M0) with predominant (≥50%)
urothelial histology

- Have clinically non-metastatic bladder cancer (N≤1 M0) determined by imaging (computed
tomography (CT) or magnetic resonance imaging (MRI) of the chest/abdomen/pelvis

- Be deemed eligible for Radical Cystectomy (RC) + Pelvic Lymph Node Dissection (PLND)

- Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Have adequate organ function

- Male and female participants are eligible to participate if they agree to the
contraception use as per study protocol

Exclusion Criteria:

- Has a known additional malignancy that is progressing or has required active
anti-cancer treatment ≤3 years of study randomization with certain exceptions

- Has received any prior systemic treatment for MIBC or non-invasive muscle bladder
cancer (NMIBC - prior treatment for NMIBC with intravesical BCG/chemotherapy is
permitted) or prior therapy with an anti- programmed cell death 1 (PD-1),
anti-programmed cell death ligand 1/ ligand 2 (PD-L1/L2), or anti-cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4)

- Has ≥N2 disease or metastatic disease (M1) as identified by imaging

- Is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility
criteria as per protocol

- Has received prior systemic anticancer therapy including investigational agents within
3 years of randomization or any radiotherapy to the bladder

- Has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC

- Has received a live or live attenuated vaccine within 30 days before the first dose of
study intervention

- Has a diagnosis of immunodeficiency or has a known history of human immunodeficiency
virus (HIV) infection, Hepatitis B infection or known active Hepatitis C infection

- Has a known psychiatric or substance abuse disorder

- Has had an allogenic tissue/solid organ transplant
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No