A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
Condition(s) studied
Investigational drug(s) / intervention(s)
Cetrelimab: Participants will receive intravenous Cetrelimab.
TAR-200: Participants will receive intravesical TAR-200.
Cisplatin: Participants will receive cisplatin intravenously.
Gemcitabine: Participants will receive gemcitabine intravenously.
Conventional radiation therapy: Participants will receive conventional radiation therapy for bladder (64 gy).
Hypo-fractioned radiation therapy: Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).
Study summary
The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.
Eligibility
Primary outcome measure(s)
- Time from Randomization to the First Bladder Intact Event-free Survival (BI-EFS) event — Up to 8 years
Time from randomization to the first BI-EFS event includes histologically proven presence of muscle-invasive bladder cancer (MIBC), clinical evidence of nodal or metastatic disease (as assessed by RECIST 1.1 criteria), radical cystectomy (RC), or death due to any cause.
Trial sites (290)
| Facility | City | Region | Status |
|---|---|---|---|
| Loma Linda Univ Faculty Medic | Loma Linda | California | |
| University of Southern California | Los Angeles | California | |
| Providence Saint John s Health Center | Santa Monica | California | |
| Stanford University Medical Center | Stanford | California | |
| The Urology Center of Colorado | Denver | Colorado | |
| Foothills Urology - Golden Off | Golden | Colorado | |
| Boca Raton Regional Hospital | Boca Raton | Florida | |
| Urological Research Network | Hialeah | Florida | |
| Memorial Healthcare System | Pembroke Pines | Florida | |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | |
| DuPage Medical Group | Lisle | Illinois | |
| University Hospitals Seidman Cancer Center | Ann Arbor | Michigan | |
| Michigan Institute of Urology | Troy | Michigan | |
| Adult Pediatric Urology & Urogynecology, P.C | Omaha | Nebraska | |
| Garden State Urology | Morristown | New Jersey | |
| New Jersey Urology LLC | Voorhees Township | New Jersey | |
| Cardiology Clinic at Montefiore Hutchinson Complex | The Bronx | New York | |
| Duke University Medical Center | Durham | North Carolina | |
| Vidant Urology - Greenville | Greenville | North Carolina | |
| Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center | Winston-Salem | North Carolina | |
| Wexner Medical Center at the Ohio State University | Columbus | Ohio | |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | |
| University of Tennessee Medical Center | Knoxville | Tennessee | |
| Houston Metro Urology | Houston | Texas | |
| University of Texas Medical Branch | League City | Texas | |
| Virginia Oncology Associates | Norfolk | Virginia | |
| Fundacion Intecnus | Bariloche | Argentina | |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | |
| Asociacion de Beneficencia Hospital Sirio Libanes | Buenos Aires | Argentina | |
| Instituto Medico Especializado Alexander Fleming | Buenos Aires | Argentina | |
| Centro de Urologia (CDU) | Ciudad Automoma Buenos Aires | Argentina | |
| Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica | Córdoba | Argentina | |
| Centro Urologico Profesor Bengio | Córdoba | Argentina | |
| Sanatorio Allende Cerro | Córdoba | Argentina | |
| Centro Oncologico Riojano Integral (Cori) | La Rioja | Argentina | |
| Centro de Investigacion Pergamino SA | Pergamino | Argentina | |
| CEDIC Centro de Investigaciones Clinicas | Viedma | Argentina | |
| Flinders Medical Centre | Bedford Park | Australia |
+ 250 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in Poland
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 NCT04658862 on ClinicalTrials.gov ↗ ← All trials in Poland