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)
TAR-200: TAR-200 will be administered intravesically.
Cetrelimab: Cetrelimab will be administered.
BCG Vesiculture: BCG will be administered intravesically.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
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
Primary outcome measure(s)
Event-free Survival (EFS) — Up to 5 years 2 months EFS is defined as the time from randomization to either the time of the first recurrence of high-risk disease, progression, or death due to any cause, whichever occurs first. For participants with carcinoma In-situ (CIS), persistent disease at 6 months (Week 24) is also considered an EFS event. Progression is defined as: an increase of stage from Ta to T1 or from CIS to T1 or progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to \[\>=\] 2) or to lymph node (N+) or to distant disease (M+), whichever occurs first.
Trial sites (240)
Facility
City
Region
Status
Mayo Clinic
Scottsdale
Arizona
Arkansas Urology
Little Rock
Arkansas
VA Long Beach Health Care System
Long Beach
California
Genesis Research, LLC - West Coast Urology
Los Alamitos
California
Cedars Sinai Medical Center
Los Angeles
California
UC Davis Comprehensive Cancer Center
Sacramento
California
Genesis Research
San Diego
California
Providence Saint Johns Cancer Institute
Santa Monica
California
Providence Medical Foundation
Santa Rosa
California
Colorado Clinical Research
Lakewood
Colorado
Urological Research Network
Hialeah
Florida
Orlando Health Cancer Institute
Orlando
Florida
Sarasota Memorial Hospital
Sarasota
Florida
Grady Memorial Hospital
Atlanta
Georgia
The Emory Clinic Department of Urology
Atlanta
Georgia
Northwestern University
Chicago
Illinois
Duly Health and Care
Lisle
Illinois
Blessing Hospital
Quincy
Illinois
Urology of Indiana
Carmel
Indiana
First Urology
Jeffersonville
Indiana
AMR Kansas City Oncology
Merriam
Kansas
Wichita Urology Group
Wichita
Kansas
Chesapeake Urology Research Associates
Hanover
Maryland
Lahey Hospital & Medical Center
Burlington
Massachusetts
University of Michigan
Ann Arbor
Michigan
University Of Minnesota
Minneapolis
Minnesota
Mayo Clinic Rochester
Rochester
Minnesota
The Urology Center, PC
Omaha
Nebraska
Cooper Health System MD Anderson Cancer Center at Cooper
Camden
New Jersey
VA NY Harbor Healthcare System
New York
New York
Icahn School of Medicine at Mt. Sinai
New York
New York
Associated Medical Professionals of Ny
Syracuse
New York
SUNY Upstate Med Univ
Syracuse
New York
Vidant Urology - Greenville
Greenville
North Carolina
Cleveland Clinic
Cleveland
Ohio
Central Ohio Urology Group
Gahanna
Ohio
Centers for Advanced Urology LLC d b a MidLantic Urology
Bala-Cynwyd
Pennsylvania
Thomas Jefferson University Hospital
Philadelphia
Pennsylvania
UPMC Shadyside Hospital
Pittsburgh
Pennsylvania
Carolina Urologic Research Center
Myrtle Beach
South Carolina
+ 200 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in the UK
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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