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

Running, not enrolling · Phase 3

Conditions studied: Urinary Bladder Neoplasms

In brief

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.

Key facts

Study ID

NCT04658862

Run by

Janssen Research & Development, LLC

People needed

518

Starts

2020-12-07

Expected to finish

2028-12-31

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Southern California — Los Angeles, California, United States
• Providence Saint John s Health Center — Santa Monica, California, United States
• Stanford University Medical Center — Stanford, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Foothills Urology - Golden Off — Golden, Colorado, United States
• Boca Raton Regional Hospital — Boca Raton, Florida, United States
• Urological Research Network — Hialeah, Florida, United States
• Memorial Healthcare System — Pembroke Pines, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• DuPage Medical Group — Lisle, Illinois, United States
• University Hospitals Seidman Cancer Center — Ann Arbor, Michigan, United States
• Michigan Institute of Urology — Troy, Michigan, United States
• Adult Pediatric Urology & Urogynecology, P.C — Omaha, Nebraska, United States
• Garden State Urology — Morristown, New Jersey, United States
• New Jersey Urology LLC — Voorhees Township, New Jersey, United States
• Cardiology Clinic at Montefiore Hutchinson Complex — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Vidant Urology - Greenville — Greenville, North Carolina, United States
• Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
• Wexner Medical Center at the Ohio State University — Columbus, Ohio, United States
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• MidLantic Urology — Bala-Cynwyd, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• University of Tennessee Medical Center — Knoxville, Tennessee, United States
• Loma Linda Univ Faculty Medic — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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