• Determine the clinical complete response rate (cT0 or cTa) with gemcitabine, cisplatin, plus nivolumab [ Time Frame: 24 months ]
  Clinical complete response rate will be defined as cT0 or cTa disease after gemcitabine, cisplatin, plus nivolumab.
• Determine the ability of clinical complete response (cT0 or cTa) to predict benefit from treatment. [ Time Frame: 24 months ]
  Benefit will be defined as a pathologic complete response (<pT1) in patients undergoing cystectomy and 2 year metastasis-free in patients pursuing surveillance

• Assess Adverse Events [ Time Frame: 24 months ]
  Assess adverse events according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4
• Bladder intact overall survival [ Time Frame: 24 Months ]
  Bladder-intact overall survival is defined as the time from initiation of treatment until death or cystectomy
• Recurrence-free survival [ Time Frame: 24 months ]
  Recurrence-free survival is defined as the time from initiation of treatment to death or recurrence, depending on which occurs first
• Pathologic complete response rate in patients undergoing cystectomy [ Time Frame: 24 Months ]
  Pathologic complete response rate in patients undergoing radical cystectomy is defined as the proportion of patients with <pT1
• Determine the association between a prespecified panel of genomic biomarkers and benefit from treatment in patients achieving a clinical complete response. [ Time Frame: 24 months ]
  Benefit will be defined as a pathologic complete response (p<T1) in patients undergoing cystectomy and 2 years metastasis-free in patients pursuing surveillance

• Drug: Nivolumab
  Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
  Other Name: Opdivo
• Drug: Gemcitabine
  Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles.
  Other Name: Gemzar
• Drug: Cisplatin
  Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.
  Other Name: Platinol

Inclusion Criteria:

• ECOG Performance Status of ≤ 1 within 28 days prior to registration.
• Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder (i.e., ct2-4n0m0). candidate for cystectomy as per treating physician.
• Demonstrate adequate organ function per listed criteria:
• Absolute Neutrophil Count (ANC): ≥ 1.5 x 10^9/L
• Hemoglobin (Hgb): ≥ 9 g/dL
• Platelets: ≥ 100 x 10^9/L
• Calculated creatinine clearance: Creatinine ≤ 1.5 or creatinine clearance ≥ 60 mL/min
• Bilirubin: ≤ 1.5 × upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
• Aspartate aminotransferase (AST) : ≤ 3 × ULN
• Alanine aminotransferase (ALT) : ≤ 3 × ULN
• All subjects must have adequate archival tissue identified at screening (i.e., at least 15 unstained slides or paraffin block).
• Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception.
• Women of childbearing potential must have a negative serum or urine pregnancy within 7 days prior to C1D1.

Exclusion Criteria:

• Prior treatment with systemic chemotherapy for muscle-invasive urothelial cancer of the bladder
• Active infection requiring systemic therapy
• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
• Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
• Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
• Grade ≥ 2 neuropathy (NCI CTCAE version 4).
• Prior radiation therapy for bladder cancer
• Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (RNA) or hepatitis C antibody (HCV antibody) indicating acute or chronic infection.
• Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• Evidence of interstitial lung disease or active, non-infectious pneumonitis.
• Solid organ or allogeneic stem cell transplant

• Bristol-Myers Squibb
• Icahn School of Medicine at Mount Sinai