Primary Outcomes:

Primary Outcome 1 - Measure: Overall survival

Primary Outcome 1 - Time Frame: From randomization to the date of death from any cause, assessed up to 5 years

Primary Outcome 2 - Measure: Disease-free survival

Primary Outcome 2 - Time Frame: From randomization to the first metastatic recurrence (presence of any recurrent disease), or death, whichever occurs first, assessed up to 5 years

Condition:

• Stage II Bladder Urothelial Carcinoma AJCC v6 and v7
• Stage III Bladder Urothelial Carcinoma AJCC v6 and v7

Eligibility

Criteria:
Inclusion Criteria:

- PRE-REGISTRATION ELIGIBILITY CRITERIA

- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper
tract; variant histology allowed as long as urothelial carcinoma is predominant (>
50%); pure small-cell carcinoma is excluded

- Paraffin tissue samples obtained by transurethral resection of muscle-invasive bladder
tumor, upper tract resection, cystectomy/nephrectomy/ureterectomy, or
nephroureterectomy must be available; this specimen submission is mandatory prior to
registration as results will be used for stratification

- Patient must fit into one of the following three categories:

- Patients who received neoadjuvant chemotherapy and pathologic stage at surgical
resection is >= pT2 and/or N+ OR

- Patients who are not cisplatin-eligible (according to >= 1 of the following
criteria: Eastern Cooperative Oncology Group [ECOG] performance status of 2,
creatinine clearance < 60 mL/min, grade >= 2 hearing loss, grade >= 2 neuropathy,
or New York Heart Association class III heart failure and pathologic stage at
surgical resection is >= pT3 or pN+) OR

- Patients that decline adjuvant cisplatin-based or other systemic chemotherapy
based on an informed discussion with the physician and pathologic stage at
surgical resection is >= pT3 or pN+

- Patient must have had radical surgical resection of their bladder cancer >= 4 weeks
but =< 16 weeks prior to pre-registration

- No invasive cancer at the surgical margins

- No evidence of residual cancer or metastasis after surgery

- No metastatic disease on cross-sectional imaging (according to Response Evaluation
Criteria in Solid Tumors [RECIST] version [v]1.1 criteria)

- No active autoimmune disease or history of autoimmune disease that might recur, which
may affect vital organ function or require immune suppressive treatment including
systemic corticosteroids; these include but are not limited to patients with a history
of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating)
neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease
such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma,
inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients
with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or
phospholipid syndrome because of the risk of recurrence or exacerbation of disease;
human immunodeficiency virus (HIV) (+) patients are eligible as long as they have: cd4
> 200, undetectable viral load and on highly active antiretroviral therapy (HAART)
therapy

- No current pneumonitis or prior history of non-infectious pneumonitis that required
steroids within the previous 5 years

- Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus,
thyroiditis managed with replacement hormones including physiologic corticosteroids
are eligible

- Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and
psoriasis controlled with topical medication and patients with positive serology, such
as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the
presence of target organ involvement and potential need for systemic treatment but
should otherwise be eligible

- No known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or
hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is
detected)

- No postoperative/adjuvant systemic therapy

- No prior treatment with any therapy on the PD-1/PD-L1 axis

- No treatment with any other type of investigational agent =< 4 weeks before
pre-registration

- No major surgery =< 4 weeks before pre-registration

- No radiation therapy =< 4 weeks before pre-registration

- No neoadjuvant chemotherapy =< 4 weeks before pre-registration

- Not pregnant and not nursing

- ECOG performance status =< 2

- Absolute neutrophil count (ANC) >= 1,200/mm^3

- Leukocytes >= 3,000/ mm^3

- Platelet count >= 75,000/mm^3

- Hemoglobin >= 9 g/dL or >= 5.6 mmol/L

- Creatinine =< 2.0 x upper limit of normal (ULN) OR calculated (calc.) creatinine
clearance >= 30 mL/min

- Total bilirubin =< 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x upper limit
of normal (ULN)

- Serum albumin >= 2.8 g/dL

- For women of childbearing potential only: a negative urine or serum pregnancy test
done =< 7 days prior to pre-registration is required

- REGISTRATION ELIGIBILITY CRITERIA

- Results of central PD-L1 testing available; Q2 Solutions will forward the PD-L1
results to the statistical center and the statistical center will notify the site that
the result is available; the notification from the Alliance registration/randomization
office will serve as a confirmation of this eligibility criteria; after sites receive
the confirmation e-mail from Alliance they can register the patient
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No