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)
Public ClinicalTrials.gov record NCT05714202. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05714202
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,135 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 23, 2023 (Actual)
- Primary completion
- Sep 18, 2029 (Estimated)
- Completion
- Sep 18, 2029 (Estimated)
- Last update posted
- Sep 25, 2026
2023 – 2029
United States locations
- U.S. sites
- 51
- U.S. states
- 25
- U.S. cities
- 45
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| Arkansas Urology | Little Rock | Arkansas | 72211 | — |
| VA Long Beach Health Care System | Long Beach | California | 90822 | — |
| Genesis Research, LLC - West Coast Urology | Los Alamitos | California | 90720 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95630 | — |
| Genesis Research | San Diego | California | 92123 | — |
| Providence Saint Johns Cancer Institute | Santa Monica | California | 90404 | — |
| Providence Medical Foundation | Santa Rosa | California | 95403 | — |
| Colorado Clinical Research | Lakewood | Colorado | 80228 | — |
| Urological Research Network | Hialeah | Florida | 33016 | — |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | — |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | — |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | — |
| The Emory Clinic Department of Urology | Atlanta | Georgia | 30322 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Duly Health and Care | Lisle | Illinois | 60532 | — |
| Blessing Hospital | Quincy | Illinois | 62301 | — |
| Urology of Indiana | Carmel | Indiana | 46032 | — |
| First Urology | Jeffersonville | Indiana | 47130 | — |
| AMR Kansas City Oncology | Merriam | Kansas | 66204 | — |
| Wichita Urology Group | Wichita | Kansas | 67226 | — |
| Chesapeake Urology Research Associates | Hanover | Maryland | 21076 | — |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University Of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| The Urology Center, PC | Omaha | Nebraska | 68114 | — |
| Cooper Health System MD Anderson Cancer Center at Cooper | Camden | New Jersey | 08103 | — |
| VA NY Harbor Healthcare System | New York | New York | 10010 | — |
| Icahn School of Medicine at Mt. Sinai | New York | New York | 10029 | — |
| Associated Medical Professionals of Ny | Syracuse | New York | 13210 | — |
| SUNY Upstate Med Univ | Syracuse | New York | 13210 | — |
| Vidant Urology - Greenville | Greenville | North Carolina | 27834 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Central Ohio Urology Group | Gahanna | Ohio | 43230 | — |
| Centers for Advanced Urology LLC d b a MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| UPMC Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Urology Associates | Nashville | Tennessee | 37209 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Urology Austin | Austin | Texas | 78745 | — |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | — |
| Houston Metro Urology | Houston | Texas | 77027 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Urology San Antonio Research | San Antonio | Texas | 78229 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| George E. Wahlen VAMC | Salt Lake City | Utah | 84148 | — |
| Urology Of Virginia, Pllc | Virginia Beach | Virginia | 23462 | — |
| Spokane Urology | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 189 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05714202, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2026 · Synced Oct 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05714202 live on ClinicalTrials.gov.