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)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 Netherlands
Other trials for the same condition
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.
View NCT05714202 on ClinicalTrials.gov ↗ ← All trials in the Netherlands