Primary Outcomes:

Primary Outcome 1 - Measure: Pathologic complete response (pCR) rate of neoadjuvant nivolumab + bempeg to Standard of Care (SOC) in all randomized participants

Primary Outcome 1 - Time Frame: Approximately 36 months

Primary Outcome 2 - Measure: Event-free survival (EFS) of neoadjuvant nivolumab + bempeg followed by adjuvant nivolumab + bempeg after RC vs. SOC

Primary Outcome 2 - Time Frame: Approximately 54 months

Condition:

• Bladder Cancer
• Bladder Tumor
• Muscle-Invasive Bladder Cancer

Eligibility

Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- MIBC, clinical stage T2-T4a, N0, M0, diagnosed at transurethral resection of bladder
tumor (TURBT) and confirmed by radiographic imaging.

- Must be deemed eligible for Radical Cystectomy (RC) by urologist, and must agree to
undergo RC. For arms A and B, participants must agree to undergo RC after completion
of neoadjuvant therapy.

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

- Cisplatin-ineligible participants will be defined by any one of the following
criteria:

i) Impaired renal function (glomerular filtration rate [GFR] ≥ 30 but < 60 mL/min) ii)
GFR should be assessed by direct measurement (ie, creatinine clearance) or, if not
available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula) iii)
Common Terminology Criteria for Adverse Events (CTCAE) version 5, ≥ Grade 2 hearing
loss (assessed per local SOC).

iv) CTCAE version 5, ≥ Grade 2 peripheral neuropathy.

- Documented Left Ventricular Ejection Fraction (LVEF) more than 45%

- Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

- Clinical evidence of pathologic lymph node (LN) or metastatic bladder cancer.

- Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than
TURBT or biopsies is not permitted. Prior Bacillus Calmette-Guerin (BCG) or other
intravesicular treatment of non-muscle invasive bladder cancer (NMIBC) is permitted if
completed at least 6 weeks prior to initiating study treatment.

- Evidence of urothelial carcinoma (UC) in upper urinary tracts (ureters or renal
pelvis) or history of previous MIBC

- History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically
significant venous or non-CVA(cerebrovascular accident)/TIA (Transient ischemic
attack) arterial thromboembolic event

Other protocol-defined inclusion/exclusion criteria apply
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No