Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: TAR-200 + Cetrelimab
Participants will receive TAR-200 in combination with cetrelimab.
  • Drug: TAR-200
    TAR-200 will be administered.
    Other names:
    • JNJ-17000139
  • Biological: Cetrelimab
    Cetrelimab will be administered.
    Other names:
    • JNJ-63723283
Experimental
Cohort 2: Cetrelimab
Participants will receive cetrelimab.
  • Biological: Cetrelimab
    Cetrelimab will be administered.
    Other names:
    • JNJ-63723283

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

UAMS Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas 72205

Arkansas Urology
Little Rock, Arkansas 72211

Genesis Research
San Diego, California 92123

Colorodo Urology- St. Anthony Hospital
Golden, Colorado 80401

University of Florida Health Jacksonville
Jacksonville, Florida 32209

Mayo Clinic
Jacksonville, Florida 32224

Baptist Hospital of Miami
Miami, Florida 33176

Winship Cancer Institute Emory University
Atlanta, Georgia 30322

DuPage Medical Group
Lisle, Illinois 60532

Urology of Indiana
Indianapolis, Indiana 46260

First Urology
Jeffersonville, Indiana 47130

University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky 40202

University Of Maryland Medical Center
Baltimore, Maryland 21201

Penn Medicine - PerelmanCenter for Advanced Medicine
Baltimore, Maryland 21218

Brigham and Women's Hospital
Boston, Massachusetts 02115

Michigan Institute of Urology, PC
Troy, Michigan 48084

University Of Minnesota
Minneapolis, Minnesota 55455

Mayo Clinic
Rochester, Minnesota 55905

Ellis Fischel Cancer Center
Columbia, Missouri 65201

Washington University School Of Medicine - Center For Advanced Medicine (CAM)
Saint Louis, Missouri 63110-1010

Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901

Mount Sinai Queens Infusion Center
Astoria, New York 11102

Montefiore Medical Center
Bronx, New York 10467

New York University Langone Medical Center
New York, New York 10017

Memorial Sloan Kettering Cancer Center
New York, New York 10065

SUNY Upstate Medical University
Syracuse, New York 13202

Associated Medical Professionals
Syracuse, New York 13210

Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem, North Carolina 27103

The Ohio State University
Columbus, Ohio 43210

MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004

University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania 15232

Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572

Urology Associates
Nashville, Tennessee 37209

Houston Metro Urology
Houston, Texas 77027

Urology San Antonio Research
San Antonio, Texas 78229

Huntsman Cancer Institute
Salt Lake City, Utah 84112

University of Washington School of Medicine
Seattle, Washington 98195

More Details

NCT ID
NCT04919512
Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study@its.jnj.com

Detailed Description

Bladder cancer is the tenth most common malignancy worldwide. Approximately 25 percent (%) of all new bladder cancer participants present with muscle invasive bladder cancer (MIBC) at the time of diagnosis, and roughly 50% will ultimately develop distant metastases. The TAR-200/ gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine minitablets and osmotic minitablets. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin G4 (IgG4) kappa monoclonal antibody (mAb) that binds programmed-cell death protein (PD)-1. The standard of care in MIBC includes radical cystectomy (RC) with urinary diversion and is considered the preferred treatment option for participants who are considered surgical candidates. Study consists of a Screening phase, Treatment phase and follow-up phase. The total duration of study will be up to 2 years and 6 months. Efficacy, safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during this study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.