NCT06319820From ClinicalTrials.govRecruiting

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

A Phase 3, Randomized Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Single Agent Intravesical Chemotherapy in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (IR-NMIBC) and Susceptible FGFR Alterations

Non-Muscle Invasive Bladder Neoplasms

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Janssen Research & Development, LLC
Enrolment target: 641
Started: 18 April 2024
Main results due: 28 June 2028
Study sites: 193
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(193)

Arkansas Urology
Little Rock, Arkansas, United States
Completed
Genesis Research LLC
Los Alamitos, California, United States
Active, not recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Active, not recruiting
University of California Irvine Medical Center
Orange, California, United States
Active, not recruiting
Om Research LLC
San Diego, California, United States
Active, not recruiting
Genesis Research LLC 1
Sherman Oaks, California, United States
Completed
University of Colorado Cancer Center Anschultz Cancer Pavilion
Aurora, Colorado, United States
Completed
Colorado Clinical Research
Lakewood, Colorado, United States
Active, not recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Active, not recruiting
Northwestern University
Chicago, Illinois, United States
Completed
First Urology
Jeffersonville, Indiana, United States
Completed
Wichita Urology Group
Wichita, Kansas, United States
Active, not recruiting
Ochsner Health System
New Orleans, Louisiana, United States
Active, not recruiting
Chesapeake Urology Research Associates
Hanover, Maryland, United States
Completed
Brigham And Women's Hospital
Boston, Massachusetts, United States
Completed
Karmanos Cancer Institute
Detroit, Michigan, United States
Active, not recruiting
Comprehensive Urology
Royal Oak, Michigan, United States
Active, not recruiting
Mercy Research
St Louis, Missouri, United States
Completed
Specialty Clinical Research of St Louis
St Louis, Missouri, United States
Active, not recruiting
The Urology Center, PC
Omaha, Nebraska, United States
Active, not recruiting
Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States
Active, not recruiting
Integrated Medical Professionals
New York, New York, United States
Completed
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Active, not recruiting
Associated Medical Professionals of Ny
Syracuse, New York, United States
Active, not recruiting
SUNY Upstate Med Univ
Syracuse, New York, United States
Active, not recruiting
Levine Cancer Institute
Charlotte, North Carolina, United States
Active, not recruiting
Associated Urologists of North Carolina
Raleigh, North Carolina, United States
Active, not recruiting
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Completed
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
Active, not recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Active, not recruiting
The Conrad Pearson Clinic
Germantown, Tennessee, United States
Active, not recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Completed
Urology Associates
Nashville, Tennessee, United States
Active, not recruiting
Urology Austin
Austin, Texas, United States
Active, not recruiting
Urology Clinics of North Texas
Dallas, Texas, United States
Active, not recruiting
UT Southwestern
Dallas, Texas, United States
Completed
Houston Metro Urology
Houston, Texas, United States
Active, not recruiting
Spokane Urology
Spokane, Washington, United States
Active, not recruiting
Hospital Sirio Libanes
Buenos Aires, Argentina
Active, not recruiting
Investigaciones Clinico Moleculares (ICM)
CABA, Argentina
Active, not recruiting
Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica
Córdoba, Argentina
Active, not recruiting
Centro Urologico Profesor Bengio
Córdoba, Argentina
Active, not recruiting
Hospital Privado de la Comunidad
Mar del Plata, Argentina
Active, not recruiting
Sanatorio de la Mujer
Rosario, Argentina
Active, not recruiting
Medizinische Universitaet Graz
Graz, Austria
Recruiting
Medizinische Universitat Innsbruck
Innsbruck, Austria
Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria
Recruiting
Universitaetsklinikum Salzburg Landeskrankenhaus
Salzburg, Austria
Recruiting
Medical University Vienna MUV
Vienna, Austria
Recruiting
AZORG campus Aalst Moorselbaan
Aalst, Belgium
Recruiting
AZ Sint-Jan
Bruges, Belgium
Recruiting
UZ Antwerpen
Edegem, Belgium
Completed
AZ Maria Middelares
Ghent, Belgium
Recruiting
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium
Active, not recruiting
Vitaz
Sint-Niklaas, Belgium
Recruiting
CHU UCL Namur - Site Godinne
Yvoir, Belgium
Recruiting
Fundacao Pio XII
Barretos, Brazil
Active, not recruiting
Universidade Estadual De Campinas
Campinas, Brazil
Completed
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
Active, not recruiting
Hospital Moinhos de Vento
Porto Alegre, Brazil
Active, not recruiting

Showing 60 of 193 sites — filter to narrow it down. 83 of the 193 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06319820. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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