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

A Phase 3, Multi-center, Randomized Study Evaluating Efficacy of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-Invasive Urothelial Carcinoma (MIBC) of the Bladder Who Are Not Receiving Radical Cystectomy

INTRODUCTION

  • Org Study ID: CR108917
  • Secondary ID: N/A
  • NCT ID: NCT04658862
  • Sponsor: Janssen Research & Development, LLC

BRIEF SUMMARY

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.

  • Overall Status
    Recruiting
  • Start Date
    December 7, 2020
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Urinary Bladder Neoplasms

ELIGIBILITY

Inclusion Criteria:
* 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
Exclusion Criteria:
* 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Janssen Research & Development, LLC Clinical Trials

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: Loma Linda Univ Faculty Medic
Loma Linda, California 92354
United States
Status: Recruiting Contact: N/A
Facility: University of Southern California
Los Angeles, California 90033
United States
Status: Recruiting Contact: N/A
Facility: Providence Saint John's Health Center
Santa Monica, California 90404
United States
Status: Recruiting Contact: N/A
Facility: Stanford University Medical Center
Stanford, California 94305
United States
Status: Recruiting Contact: N/A
Facility: Foothills Urology - Golden Off
Golden, Colorado 80401
United States
Status: Recruiting Contact: N/A
Facility: Boca Raton Regional Hospital
Boca Raton, Florida 33486
United States
Status: Recruiting Contact: N/A
Facility: Urological Research Network
Hialeah, Florida 33016
United States
Status: Recruiting Contact: N/A
Facility: Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: N/A
Facility: DuPage Medical Group
Lisle, Illinois 60532
United States
Status: Recruiting Contact: N/A
Facility: Adult Pediatric Urology & Urogynecology, P.C
Omaha, Nebraska 68114
United States
Status: Recruiting Contact: N/A
Facility: Cardiology Clinic at Montefiore Hutchinson Complex
Bronx, New York 10461
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: Wexner Medical Center at the Ohio State University
Columbus, Ohio 43210
United States
Status: Recruiting Contact: N/A
Facility: Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: N/A
Facility: MidLantic Urology
Bala-Cynwyd, Pennsylvania 19004
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: University of Tennessee Medical Center
Knoxville, Tennessee 37920
United States
Status: Recruiting Contact: N/A
Facility: Houston Metro Urology
Houston, Texas 77027
United States
Status: Recruiting Contact: N/A
Facility: University of Texas Medical Branch
League City, Texas 77573
United States
Status: Recruiting Contact: N/A
Facility: Virginia Oncology Associates
Norfolk, Virginia 23502
United States
Status: Recruiting Contact: N/A