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Clinical Trials in the USA / NCT04658862
Active, not recruiting Phase 3

A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

NCT04658862 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2020-12-07
Last updated
2026-08-28

Condition(s) studied

Urinary Bladder Neoplasms

Investigational drug(s) / intervention(s)

CetrelimabTAR-200CisplatinGemcitabineConventional radiation therapyHypo-fractioned radiation therapy

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)

Trial sites (290)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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 the USA