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Clinical Trials in the UK / NCT05714202
Active, not recruiting Phase 3

A Study 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 (HR-NMIBC)

NCT05714202 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2023-03-23
Last updated
2026-08-28

Condition(s) studied

Bladder Cancer

Investigational drug(s) / intervention(s)

TAR-200CetrelimabBCG Vesiculture

TAR-200: TAR-200 will be administered intravesically.

Cetrelimab: Cetrelimab will be administered.

BCG Vesiculture: BCG will be administered intravesically.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (240)

FacilityCityRegionStatus
Mayo Clinic Scottsdale Arizona
Arkansas Urology Little Rock Arkansas
VA Long Beach Health Care System Long Beach California
Genesis Research, LLC - West Coast Urology Los Alamitos California
Cedars Sinai Medical Center Los Angeles California
UC Davis Comprehensive Cancer Center Sacramento California
Genesis Research San Diego California
Providence Saint Johns Cancer Institute Santa Monica California
Providence Medical Foundation Santa Rosa California
Colorado Clinical Research Lakewood Colorado
Urological Research Network Hialeah Florida
Orlando Health Cancer Institute Orlando Florida
Sarasota Memorial Hospital Sarasota Florida
Grady Memorial Hospital Atlanta Georgia
The Emory Clinic Department of Urology Atlanta Georgia
Northwestern University Chicago Illinois
Duly Health and Care Lisle Illinois
Blessing Hospital Quincy Illinois
Urology of Indiana Carmel Indiana
First Urology Jeffersonville Indiana
AMR Kansas City Oncology Merriam Kansas
Wichita Urology Group Wichita Kansas
Chesapeake Urology Research Associates Hanover Maryland
Lahey Hospital & Medical Center Burlington Massachusetts
University of Michigan Ann Arbor Michigan
University Of Minnesota Minneapolis Minnesota
Mayo Clinic Rochester Rochester Minnesota
The Urology Center, PC Omaha Nebraska
Cooper Health System MD Anderson Cancer Center at Cooper Camden New Jersey
VA NY Harbor Healthcare System New York New York
Icahn School of Medicine at Mt. Sinai New York New York
Associated Medical Professionals of Ny Syracuse New York
SUNY Upstate Med Univ Syracuse New York
Vidant Urology - Greenville Greenville North Carolina
Cleveland Clinic Cleveland Ohio
Central Ohio Urology Group Gahanna Ohio
Centers for Advanced Urology LLC d b a MidLantic Urology Bala-Cynwyd Pennsylvania
Thomas Jefferson University Hospital Philadelphia Pennsylvania
UPMC Shadyside Hospital Pittsburgh Pennsylvania
Carolina Urologic Research Center Myrtle Beach South Carolina

+ 200 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05714202 on ClinicalTrials.gov ↗ ← All trials in the UK