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Clinical Trials in the USA / NCT06319820
Recruiting Phase 3

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

NCT06319820 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2024-04-18
Last updated
2026-08-28

Condition(s) studied

Non-Muscle Invasive Bladder Neoplasms

Investigational drug(s) / intervention(s)

TAR-210GemcitabineMMC

TAR-210: TAR-210 will be administered intravesically.

Gemcitabine: Gemcitabine will be administered intravesically.

MMC: MMC will be administered intravesically.

Study summary

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Main study only: Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (\>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor \>= 3 cm, iii. Early recurrence (less than \[\<\] 1 year), iv. Frequent recurrence (greater than \[\>\] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor) * Substudy only: Have a histologically confirmed new diagnosis (within 90 days of randomization) of IR-NMIBC for whom MMC is deemed the therapy of choice according to local standard of care with at least 1 of the following criteria fulfilled: a. Ta LG/G1, b. Ta LG/G2, and \>=1 of the following risk factors: i) Multiple Ta LG tumors, ii) Solitary LG tumor \>=3 cm * Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing * Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm. * Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy * Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment * Have an Eastern Cooperative Oncology Group performance status of 0 to 2 Exclusion Criteria: * Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs * Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy * Polyuria with recorded 24-hour urine volumes \> 4000 milliliters (mL) * Current indwelling urinary catheters, however, intermittent catheterization is acceptable * Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery) Substudy: \- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis

Primary outcome measure(s)

Trial sites (193)

FacilityCityRegionStatus
Arkansas Urology Little Rock Arkansas Completed
Genesis Research LLC Los Alamitos California Active Not Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Active Not Recruiting
University of California Irvine Medical Center Orange California Active Not Recruiting
Om Research LLC San Diego California Active Not Recruiting
Genesis Research LLC 1 Sherman Oaks California Completed
University of Colorado Cancer Center Anschultz Cancer Pavilion Aurora Colorado Completed
Colorado Clinical Research Lakewood Colorado Active Not Recruiting
Moffitt Cancer Center Tampa Florida Active Not Recruiting
Northwestern University Chicago Illinois Completed
First Urology Jeffersonville Indiana Completed
Wichita Urology Group Wichita Kansas Active Not Recruiting
Ochsner Health System New Orleans Louisiana Active Not Recruiting
Chesapeake Urology Research Associates Hanover Maryland Completed
Brigham And Women's Hospital Boston Massachusetts Completed
Karmanos Cancer Institute Detroit Michigan Active Not Recruiting
Comprehensive Urology Royal Oak Michigan Active Not Recruiting
Mercy Research St Louis Missouri Completed
Specialty Clinical Research of St Louis St Louis Missouri Active Not Recruiting
The Urology Center, PC Omaha Nebraska Active Not Recruiting
Cancer Institute Of New Jersey New Brunswick New Jersey Active Not Recruiting
Integrated Medical Professionals New York New York Completed
Memorial Sloan Kettering Cancer Center New York New York Active Not Recruiting
Associated Medical Professionals of Ny Syracuse New York Active Not Recruiting
SUNY Upstate Med Univ Syracuse New York Active Not Recruiting
Levine Cancer Institute Charlotte North Carolina Active Not Recruiting
Associated Urologists of North Carolina Raleigh North Carolina Active Not Recruiting
MidLantic Urology Bala-Cynwyd Pennsylvania Completed
Keystone Urology Specialists Lancaster Pennsylvania Active Not Recruiting
Carolina Urologic Research Center Myrtle Beach South Carolina Active Not Recruiting
The Conrad Pearson Clinic Germantown Tennessee Active Not Recruiting
University of Tennessee Medical Center Knoxville Tennessee Completed
Urology Associates Nashville Tennessee Active Not Recruiting
Urology Austin Austin Texas Active Not Recruiting
Urology Clinics of North Texas Dallas Texas Active Not Recruiting
UT Southwestern Dallas Texas Completed
Houston Metro Urology Houston Texas Active Not Recruiting
Spokane Urology Spokane Washington Active Not Recruiting
Hospital Sirio Libanes Buenos Aires Argentina Active Not Recruiting
Investigaciones Clinico Moleculares (ICM) CABA Argentina Active Not Recruiting

+ 153 more sites — see the full list on the official registry below.

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 NCT06319820 on ClinicalTrials.gov ↗ ← All trials in the USA