Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of Treatment Emergent Adverse Events (safety and tolerability)

Primary Outcome 1 - Time Frame: Up to End of Treatment (Month 6 for Group 1 and Day 45 for Group 2)

Condition:

• Bladder Cancer
• Urothelial Carcinoma
• Urinary Bladder Neoplasm
• Urinary Bladder Cancer
• Urogenital Neoplasms
• Urologic Neoplasms
• Urologic Cancer
• Malignant Tumor of the Urinary Bladder
• Cancer of the Bladder

Eligibility

Criteria:
Inclusion Criteria:

- Signed informed consent;

- Age ≥18 years;

- Patients with either:

- High-risk Non-Muscle Invasive Bladder Cancer (NMIBC);

- Muscle Invasive Bladder Cancer (MIBC);

- Urothelial carcinoma confirmed by biopsy, urine cytology, computed tomography scan
(CT) or other institution-approved diagnostic methodology;

- All visible tumors removed during bladder resection (TURBT);

- Performance Status (ECOG) 0-2 at study entry;

- Life expectancy of at least 6 months;

- Adequate marrow, liver, and renal function;

- ANC ≥ 1.5 x 10^9/L;

- Hemoglobin ≥ 9.5 grams/dL;

- Platelets ≥ 75 x 10^9/L;

- Total bilirubin ≤ 1.5x institutional ULN;

- AST/ ALT ≤ 2.5x institutional ULN;

- Creatinine ≤ 1.5x institutional ULN;

- Adequate method of birth control.

Exclusion Criteria:

- Metastatic disease;

- Previous (within 12 months) or concurrent history of non-bladder malignancy, except
for non-melanoma skin cancer;

- Intravesical therapy within 6 weeks prior to consent (chemotherapy or immunotherapy
including BCG administered directly into the bladder);

- Resection surface area greater than 8 cm2;

- Upper tract and urethral disease within 18 months;

- Known hypersensitivity to any of the study drug components or reconstitution
components;

- Pregnant or breastfeeding;

- Participation in the treatment phase of another clinical trial within 3 months prior
to consent;

- Investigator's opinion of subject's probable noncompliance or inability to understand
the trial and/or give adequate informed consent;

- Ongoing drug or alcohol abuse.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No