A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

Running, not enrolling · Phase 3

Conditions studied: Bladder Cancer

In brief

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

Key facts

Study ID

NCT05714202

Run by

Janssen Research & Development, LLC

People needed

1135

Starts

2023-03-23

Expected to finish

2029-09-18

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent 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
• 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. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma [HGUC]) for patients with papillary only disease (without CIS)
• 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

You may not qualify if…

• 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

Where it is running

• SUNY Upstate Med Univ — Syracuse, New York, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• Arkansas Urology — Little Rock, Arkansas, United States
• VA Long Beach Health Care System — Long Beach, California, United States
• Genesis Research, LLC - West Coast Urology — Los Alamitos, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• Genesis Research — San Diego, California, United States
• Providence Saint Johns Cancer Institute — Santa Monica, California, United States
• Providence Medical Foundation — Santa Rosa, California, United States
• Colorado Clinical Research — Lakewood, Colorado, United States
• Urological Research Network — Hialeah, Florida, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• The Emory Clinic Department of Urology — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Duly Health and Care — Lisle, Illinois, United States
• Blessing Hospital — Quincy, Illinois, United States
• Urology of Indiana — Carmel, Indiana, United States
• First Urology — Jeffersonville, Indiana, United States
• AMR Kansas City Oncology — Merriam, Kansas, United States
• Wichita Urology Group — Wichita, Kansas, United States
• Chesapeake Urology Research Associates — Hanover, Maryland, United States
• Associated Medical Professionals of Ny — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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