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A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)

NCT06211764

Active Not RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Non-Muscle Invasive Bladder Neoplasms

Interventions: TAR-200, Mitomycin C, Gemcitabine

Countries: United States, Argentina, Belgium, Brazil, China, France, Germany, Italy

The purpose of this study is to compare disease free survival (DFS) in participants with recurrence of papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) within 1 year of last dose of Bacillus Calmette-Guérin (BCG) therapy and who refused or are unfit for Radical Cystectomy (RC), receiving TAR-200 versus investigator's choice of single agent intravesical chemotherapy.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only high-risk non-muscle-invasive bladder cancer (HR-NMIBC) \[defined as high-grade Ta or any T1, no carcinoma in situ (CIS)\]
* Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded
* Participants must be ineligible for or have elected not to undergo Radical Cystectomy (RC)
* Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2

Exclusion Criteria:

* Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, N+, and/or M+)
* 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. 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 (\>4000 mL)
* Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
* Previous treatment with TAR-200

Locations (123)

Little Rock, Arkansas, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
Torrance, California, United States
Lakewood, Colorado, United States
Riverview, Florida, United States
Chicago, Illinois, United States
Chicago Ridge, Illinois, United States
Carmel, Indiana, United States
Jeffersonville, Indiana, United States
Wichita, Kansas, United States
Royal Oak, Michigan, United States
St Louis, Missouri, United States
Syracuse, New York, United States
Cincinnati, Ohio, United States
Gahanna, Ohio, United States
Bala-Cynwyd, Pennsylvania, United States
Charleston, South Carolina, United States
Myrtle Beach, South Carolina, United States
North Charleston, South Carolina, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Spokane, Washington, United States
Buenos Aires, Argentina
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