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Brief Title: TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer

A Phase 3, Open-Label, Multi-Center, Randomized Study Evaluating the Efficacy and Safety of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-Risk Non-Muscle Invasive Bladder Cancer

INTRODUCTION

  • Org Study ID: CR109223
  • Secondary ID: N/A
  • NCT ID: NCT05714202
  • Sponsor: Janssen Research & Development, LLC

BRIEF SUMMARY

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

DETAILED DESCRIPTION

Bladder cancer is the tenth most common malignancy worldwide. About 75 percent (%) of bladder cancers are non-muscle invasive at diagnosis with approximately 25% of NMIBC patients have HR, NMIBC. The TAR-200/gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug. The drug constituent consists of gemcitabine 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 mainstay of treatment for HR-NMIBC is transurethral resection of bladder tumor, followed by intravesical treatment with BCG. In this study metronomic dosing of intravesical gemcitabine, delivered via TAR-200, alone or in combination with cetrelimab will be evaluated and compared against intravesical BCG. The study consists of a Screening phase, Treatment phase, and Follow-up phase. The total duration of the study will be up to 5 years and 2 months. Efficacy, Safety, pharmacokinetics (PK), and biomarkers will be assessed at specific time points during the study.

  • Overall Status
    Recruiting
  • Start Date
    March 23, 2023
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
* Histologically confirmed initial diagnosis by local pathology (within 90 days of the most recent signed informed consent) of high grade non-muscle invasive bladder cancer (HR-NMIBC) (high-grade Ta, any T1 or carcinoma in-situ [CIS]), in participants who are Bacillus Calmette Guérin (BCG)-naïve

- * BCG-naïve (participants who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before date of randomization are eligible)

- * All visible papillary disease must be fully resected (absent) prior to date of randomization and documented at baseline cystoscopy. Local urine cytology at screening must be negative or atypical (for high-grade urothelial carcinoma [HGUC]) for patients with papillary only disease (without CIS)

- * Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

- * 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 date of randomization - * Participants must be willing to undergo all study procedures
Exclusion Criteria:
* Presence or history of histologically confirmed, muscle invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, greater than and equal to [>=] T2)

- * Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder (that is, urethra, ureter, or renal pelvis). Ta/any T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization

- * Presence of any bladder or urethral anatomic feature (example, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-200 or administration of intravesical BCG. Participants with tumors involving the prostatic urethra in men will be excluded

- * A history of clinically significant polyuria with recorded 24-hour urine volumes greater than 4000 milliliters (mL)

- * Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

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: Mayo Clinic
Scottsdale, Arizona 85259
United States
Status: Recruiting Contact: N/A
Facility: Arkansas Urology
Little Rock, Arkansas 72211
United States
Status: Recruiting Contact: N/A
Facility: Genesis Research, LLC - West Coast Urology
Los Alamitos, California 90720
United States
Status: Recruiting Contact: N/A
Facility: Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Status: Recruiting Contact: N/A
Facility: UC Davis Comprehensive Cancer Center
Sacramento, California 95630
United States
Status: Recruiting Contact: N/A
Facility: Genesis Research
San Diego, California 92123
United States
Status: Recruiting Contact: N/A
Facility: Providence Medical Foundation
Santa Rosa, California 95403
United States
Status: Recruiting Contact: N/A
Facility: Colorado Clinical Research
Lakewood, Colorado 80228
United States
Status: Recruiting Contact: N/A
Facility: Urological Research Network
Hialeah, Florida 33016
United States
Status: Recruiting Contact: N/A
Facility: Orlando Health Cancer Institute
Orlando, Florida 32806
United States
Status: Recruiting Contact: N/A
Facility: Sarasota Memorial Hospital
Sarasota, Florida 34239
United States
Status: Recruiting Contact: N/A
Facility: The Emory Clinic Department of Urology
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: N/A
Facility: Northwestern University
Chicago, Illinois 60611
United States
Status: Recruiting Contact: N/A
Facility: Blessing Hospital
Quincy, Illinois 62301
United States
Status: Recruiting Contact: N/A
Facility: Urology of Indiana
Carmel, Indiana 46032
United States
Status: Recruiting Contact: N/A
Facility: First Urology
Jeffersonville, Indiana 47130
United States
Status: Recruiting Contact: N/A
Facility: AMR Kansas City Oncology
Merriam, Kansas 66204
United States
Status: Recruiting Contact: N/A
Facility: Wichita Urology Group
Wichita, Kansas 67226
United States
Status: Recruiting Contact: N/A
Facility: Chesapeake Urology Research Associates
Hanover, Maryland 21076
United States
Status: Recruiting Contact: N/A
Facility: Lahey Hospital & Medical Center
Burlington, Massachusetts 01805
United States
Status: Recruiting Contact: N/A
Facility: University of Michigan
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: N/A
Facility: University Of Minnesota
Minneapolis, Minnesota 55455
United States
Status: Recruiting Contact: N/A
Facility: Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: N/A
Facility: The Urology Center, PC
Omaha, Nebraska 68114
United States
Status: Recruiting Contact: N/A
Facility: VA NY Harbor Healthcare System
New York, New York 10010
United States
Status: Recruiting Contact: N/A
Facility: Associated Medical Professionals of Ny
Syracuse, New York 13210
United States
Status: Recruiting Contact: N/A
Facility: SUNY Upstate Med Univ
Syracuse, New York 13210
United States
Status: Recruiting Contact: N/A
Facility: Vidant Urology - Greenville
Greenville, North Carolina 27834
United States
Status: Recruiting Contact: N/A
Facility: Centers for Advanced Urology LLC d b a MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: N/A
Facility: Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Status: Recruiting Contact: N/A
Facility: UPMC Shadyside Hospital
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: Urology Austin
Austin, Texas 78745
United States
Status: Recruiting Contact: N/A
Facility: Urology Clinics of North Texas
Dallas, Texas 75231
United States
Status: Recruiting Contact: N/A
Facility: Houston Metro Urology
Houston, Texas 77027
United States
Status: Recruiting Contact: N/A
Facility: Houston Methodist Hospital
Houston, Texas 77030
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: George E. Wahlen VAMC
Salt Lake City, Utah 84148
United States
Status: Recruiting Contact: N/A
Facility: Urology Of Virginia, Pllc
Virginia Beach, Virginia 23462
United States
Status: Recruiting Contact: N/A
Facility: Spokane Urology
Spokane, Washington 99202
United States
Status: Recruiting Contact: N/A