Study Detail

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.