Clinical Trials

Inclusion Criteria:

- Histologically confirmed initial diagnosis by local pathology (within 90 days of the initial signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS]), in participants who are Bacillus Calmette Guérin (BCG)-naïve. Mixed histology tumors are allowed if urothelial
differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible

- BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)

- All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy

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

- 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 date of randomization

- Participants must be willing to undergo all study procedures

Exclusion Criteria:

- Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to
[>=] T2)

- Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any T1/CIS of the
upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization

- Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling
use, removal of TAR-200 or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded

- A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL)

- Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/6/23. Questions regarding updates should be directed to the study team contact.