A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Condition(s) studied
Investigational drug(s) / intervention(s)
TAR-200: TAR-200 will be administered transuretherally.
Cetrelimab: Cetrelimab will be administered.
Study summary
The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
Eligibility
Primary outcome measure(s)
- Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate — From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point. - Cohort 4: Disease-free Survival (DFS) — From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) 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 occurred first, (3) Death due to any cause.
Trial sites (144)
| Facility | City | Region | Status |
|---|---|---|---|
| Del Sol Research Management, LLC | Tucson | Arizona | |
| University of Southern California | Los Angeles | California | |
| Genesis Healthcare Partners - Genesis Research Greater Los Angeles | Sherman Oaks | California | |
| The Urology Center of Colorado | Denver | Colorado | |
| Foothills Urology - Golden Off | Golden | Colorado | |
| DuPage Medical Group | Lisle | Illinois | |
| Urology of Indiana | Greenwood | Indiana | |
| Wichita Urology Group | Wichita | Kansas | |
| Michigan Institute of Urology | Troy | Michigan | |
| NYU Langone Health | New York | New York | |
| SUNY Upstate Medical University | Syracuse | New York | |
| Associated Medical Professionals | Syracuse | New York | |
| Levine Cancer Institute | Charlotte | North Carolina | |
| The Urology Group | Cincinnati | Ohio | |
| Urologic Consultants of Southeastern Pennsylvania | Bala-Cynwyd | Pennsylvania | |
| Thomas Jefferson University | Philadelphia | Pennsylvania | |
| Urology Associates, PC | Nashville | Tennessee | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| Urology Austin | Austin | Texas | |
| University of Texas Southwestern Medical Center | Dallas | Texas | |
| Urology San Antonio Research | San Antonio | Texas | |
| Spokane Urology | Spokane | Washington | |
| Flinders Medical Centre | Bedford Park | Australia | |
| Eastern Health Research | Box Hill | Australia | |
| Macquarie University Hospital | Sydney | Australia | |
| AZ Sint-Lucas Brugge | Assebroek | Belgium | |
| AZ Sint-Jan Brugge | Bruges | Belgium | |
| Hopital Erasme | Brussels | Belgium | |
| Algemeen ziekenhuis Maria Middelares | Ghent | Belgium | |
| Universitair Ziekenhuis Gent | Ghent | Belgium | |
| Algemeen Ziekenhuis Delta | Roeselare | Belgium | |
| AZ Nikolaas | Sint-Niklaas | Belgium | |
| Exdeo Clinical Research Inc | Abbotsford British Columbia | British Columbia | |
| William Osler Health System | Brampton | Ontario | |
| Princess Margaret Hospital- UHN | Toronto | Ontario | |
| McGill University Health Centre | Montreal | Quebec | |
| Universite de Sherbrooke | Sherbrooke | Quebec | |
| Hopital Pellegrin CHU Bordeaux | Bordeaux | France | |
| Polyclinique Bordeaux Nord Acquitaine | Bordeaux | France | |
| CHU Grenoble | Grenoble | France |
+ 104 more sites — see the full list on the official registry below.
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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 NCT04640623 on ClinicalTrials.gov ↗ ← All trials in Italy