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.
