Clinical Trials

Inclusion Criteria:

- Histologically proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma of the
bladder. Initial diagnosis must have been within 90 days of randomization date.
Participants with variant histologic subtypes (example squamous differentiation) are
allowed if urothelial (transitional cell) differentiation is predominant (example,
less than [<]20 percent [%] variant histologic subtype). However, the presence of any
neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid
features will make a participant ineligible.

- Participants with an individual intravesical tumor size of less than or equal to < = 3
centimeter (cm) following transurethral resection of bladder tumor (TURBT) are
eligible. Participants with persistent multifocal tumors at screening must undergo a
second debulking, re-staging TURBT to reduce the tumor burden. Participants will be
ineligible if any individual tumor is greater than (>)3 cm.

- Deemed eligible for and willing to undergo RC by the operating urologist.

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

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

- All adverse events associated with any prior surgery must have resolved to common
terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2
prior to randomization.

Exclusion Criteria:

- Must not have received prior systemic chemotherapy, targeted small molecule therapy,
or radiation therapy within 2 years prior to starting study treatment.

- 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.

- Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time.

- Currently participating or has participated in a study of an investigational agent and
received study therapy or investigational device within 4 weeks prior to enrollment.

- Participants with evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has resolved prior to dosing.