Primary Outcomes:

Primary Outcome 1 - Measure: Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event

Primary Outcome 1 - Time Frame: Up to 8 years

Condition:

• Urinary Bladder Neoplasms

Eligibility

Criteria:
Inclusion Criteria:

- Ineligible for or have elected not to undergo radical cystectomy

- All adverse events associated with any prior surgery and/or intravesical therapy must
have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Grade less than (<) 2 prior to randomization

- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

- Thyroid function tests within normal range or stable on hormone supplementation per
investigator assessment.

- Adequate bone marrow, liver, and renal function: Bone marrow function (without the
support of cytokines or erythropoiesis-stimulating agent in preceding two weeks):
Absolute neutrophil count (ANC) greater than or equal to (>=) 1,000/cubic millimeters
(mm^3); Platelet count >=75,000/mm^3; Hemoglobin >=8.0 grams per deciliter (g/dL);
Liver function: (Total bilirubin less than or equal to (<=) 1.5 * upper limit of
normal (ULN) or direct bilirubin <= ULN for participants with total bilirubin levels
greater than (>)1.5*ULN (except participants with Gilbert's Syndrome, who must have a
total bilirubin < 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) less than or equal to (<=) 2.5* institutional ULN); Renal
function: Creatinine clearance >40 mL/min either directly measured via 24-hour urine
collection, calculation using the Cockcroft-Gault formula, or calculation for the
modification of diet in renal disease for adult participants

Exclusion Criteria:

- Must not have had urothelial carcinoma or histological variant at any site outside of
the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract
(including renal pelvis and ureter) is allowable if treated with complete
nephrouretrectomy within 24 months

- Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS
is defined as the presence of at least 4 distinct CIS lesions in the bladder at the
time of the Screening re-TURBT

- Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local
radiology staging (chest, abdomen, and pelvis must be performed using Computed
tomography [CT] or Magnetic resonance imaging [MRI]) within 42 days prior to
randomization

- Presence of any bladder or urethral anatomic feature that, in the opinion of the
investigator, may prevent the safe placement, indwelling use, or removal of TAR 200

- Evidence of bladder perforation during diagnostic cystoscopy
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No