A Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder

Completed · Phase 2

Conditions studied: Urinary Bladder Neoplasms

In brief

The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.

Key facts

Study ID

NCT04919512

Run by

Janssen Research & Development, LLC

People needed

163

Starts

2022-07-07

Expected to finish

2026-03-31

Last updated by the study team

2026-06-23

Who can join

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

You may qualify if…

• Histologically proven, cT2-T4a N0, M0 infiltrating urothelial carcinoma of the bladder. Initial diagnosis must have been within 120 days of randomization date. Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial predominance. However, the presence of small cell or neuroendocrine variants will make a participant ineligible
• Participants with no residual tumor, or intravesical tumor size of less than or equal to (<=)3 centimeter (cm) following transurethral resection of bladder tumor (TURBT) are eligible; debulking TURBT for any residual disease is encouraged but not mandated. Participants with persistent tumors greater than (>)3 cm at screening must undergo a second debulking, re-staging TURBT. Participants will be ineligible if any individual tumor is >3 cm after debulking TURBT
• Deemed eligible for and willing to undergo RC by the operating urologist
• Eastern Cooperative Oncology Group (ECOG) performance status Grade 0 or 1
• Thyroid function tests within normal range or stable on hormone supplementation per investigator assessment. Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal tests results
• All adverse events associated with any prior surgery must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade less than (<) 2 prior to randomization

You may not qualify if…

• Must not have received prior systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to starting study treatment
• Participants must not have evidence of cT4b, or N1-3, or M1 disease based on central 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
• Prior systemic chemotherapy for urothelial cell carcinoma of the bladder at any time
• Currently participating or has participated in a study of an investigational agent and received study therapy or investigational device within 4 weeks prior to enrollment
• Participants with evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has resolved prior to dosing

Where it is running

• Urological Associates of Southern Arizona, P.C. — Tucson, Arizona, United States
• UAMS Winthrop P. Rockefeller Cancer Institute — Little Rock, Arkansas, United States
• Arkansas Urology — Little Rock, Arkansas, United States
• City of Hope — Duarte, California, United States
• Genesis Research — San Diego, California, United States
• Colorodo Urology- St. Anthony Hospital — Golden, Colorado, United States
• University of Florida Health Jacksonville — Jacksonville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Winship Cancer Institute Emory University — Atlanta, Georgia, United States
• DuPage Medical Group — Lisle, Illinois, United States
• Urology of Indiana — Indianapolis, Indiana, United States
• First Urology — Jeffersonville, Indiana, United States
• University of Louisville - James Graham Brown Cancer Center — Louisville, Kentucky, United States
• University Of Maryland Medical Center — Baltimore, Maryland, United States
• Penn Medicine - PerelmanCenter for Advanced Medicine — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Michigan Institute of Urology, PC — Troy, Michigan, United States
• University Of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic 1 — Rochester, Minnesota, United States
• Ellis Fischel Cancer Center — Columbia, Missouri, United States
• Washington University School Of Medicine - Center For Advanced Medicine (CAM) — St Louis, Missouri, United States
• David C. Pratt Cancer Center — St Louis, Missouri, United States
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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