A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Ineligible for or have elected not to undergo radical cystectomy
* 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 randomization
* Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
* Thyroid function tests are within the normal range per investigator assessment (or stable on hormone supplementation). Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal test results
* Adequate bone marrow, liver, and renal function: Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): Absolute neutrophil count (ANC) greater than or equal to (\>=) 1,500/cubic millimeters (mm\^3); Platelet count \>=80,000/mm\^3; Hemoglobin \>=9.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to (\<=) 1.5 \* upper limit of normal (ULN) or direct bilirubin \<= ULN for participants with total bilirubin levels greater than (\>)1.5\*ULN (except participants with Gilbert's Syndrome, who must have a total bilirubin \< 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (\<=) 2.5\* institutional ULN); Renal function: Creatinine clearance \>=30 mL/min using the Cockcroft-Gault formula. 24-hour creatinine clearance test will also be accepted for estimating renal function in situations where Cockcroft-Gault formula is not a good predictor of estimating adequate renal function
Exclusion Criteria:
* Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study
* Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder at the time of the Screening re-TURBT
* Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using Computed tomography \[CT\] or Magnetic resonance imaging \[MRI\]) within 42 days prior to randomization
* Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 200
* Evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has healed prior to randomization
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 the USA
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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