Sex: ALL
Ages: ADULT OLDER_ADULT
Healthy Volunteers: False
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.
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
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.
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