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

A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

INTRODUCTION

  • Org Study ID: CR109044
  • Secondary ID: N/A
  • NCT ID: NCT04919512
  • Sponsor: Janssen Research & Development, LLC

BRIEF SUMMARY

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.

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.

  • Overall Status
    Recruiting
  • Start Date
    July 7, 2022
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Urinary Bladder Neoplasms

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janssen Research & Development, LLC Clinical Trial

Role: Study Director

Affiliation: Janssen Research & Development, LLC

Overall Contact

Name: Study Contact

Phone: 844-434-4210

Email: Participate-In-This-Study@its.jnj.com

LOCATION

Facility Status Contact
Facility: University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
Status: Recruiting Contact: N/A
Facility: Urological Associates of Southern Arizona, P.C.
Tucson, Arizona 85741
United States
Status: Recruiting Contact: N/A
Facility: UAMS Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas 72205
United States
Status: Recruiting Contact: N/A
Facility: Arkansas Urology
Little Rock, Arkansas 72211
United States
Status: Recruiting Contact: N/A
Facility: Genesis Research
San Diego, California 92123
United States
Status: Recruiting Contact: N/A
Facility: Colorodo Urology- St. Anthony Hospital
Golden, Colorado 80401
United States
Status: Recruiting Contact: N/A
Facility: University of Florida Health Jacksonville
Jacksonville, Florida 32209
United States
Status: Recruiting Contact: N/A
Facility: Mayo Clinic
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: N/A
Facility: Baptist Hospital of Miami
Miami, Florida 33176
United States
Status: Recruiting Contact: N/A
Facility: Winship Cancer Institute Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: N/A
Facility: Urology of Indiana
Indianapolis, Indiana 46260
United States
Status: Recruiting Contact: N/A
Facility: First Urology
Jeffersonville, Indiana 47130
United States
Status: Recruiting Contact: N/A
Facility: University Of Maryland Medical Center
Baltimore, Maryland 21201
United States
Status: Recruiting Contact: N/A
Facility: Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Status: Recruiting Contact: N/A
Facility: Michigan Institute of Urology, PC
Troy, Michigan 48084
United States
Status: Recruiting Contact: N/A
Facility: Mayo Clinic
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: N/A
Facility: Ellis Fischel Cancer Center
Columbia, Missouri 65201
United States
Status: Recruiting Contact: N/A
Facility: David C. Pratt Cancer Center
Saint Louis, Missouri 63141
United States
Status: Recruiting Contact: N/A
Facility: Mount Sinai Queens Infusion Center
Astoria, New York 11102
United States
Status: Recruiting Contact: N/A
Facility: Montefiore Medical Center
Bronx, New York 10467
United States
Status: Recruiting Contact: N/A
Facility: New York University Langone Medical Center
New York, New York 10017
United States
Status: Recruiting Contact: N/A
Facility: SUNY Upstate Medical University
Syracuse, New York 13202
United States
Status: Recruiting Contact: N/A
Facility: Associated Medical Professionals
Syracuse, New York 13210
United States
Status: Recruiting Contact: N/A
Facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center
Winston-Salem, North Carolina 27103
United States
Status: Recruiting Contact: N/A
Facility: The Ohio State University
Columbus, Ohio 43210
United States
Status: Recruiting Contact: N/A
Facility: MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: N/A
Facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: N/A
Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: N/A
Facility: Urology Associates
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: N/A
Facility: Houston Metro Urology
Houston, Texas 77027
United States
Status: Recruiting Contact: N/A
Facility: Urology San Antonio Research
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact: N/A
Facility: University of Washington School of Medicine
Seattle, Washington 98195
United States
Status: Recruiting Contact: N/A