Recruiting

Phase 3

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

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06319820

Conditions

Non-Muscle Invasive Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TAR-210

Gemcitabine

MMC

Study Details

Brief 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.

Conditions

Non-Muscle Invasive Bladder Cancer

Study ID

NCT06319820

Start date

Apr 18, 2024

Status verified date

Dec, 2025

Completion date

Jun 28, 2028

Anticipated

Primary completion date

Jun 28, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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)
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)

Study Design

Enrollment

641 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A: TAR-210

Participants in Group A will have TAR-210 inserted in the bladder on Day 1 and removed after 12 weeks. One TAR-210 will be inserted every 12 weeks over a treatment period of approximately 1 year.

active comparator: Group B: MMC or Gemcitabine

Participants in Group B will receive intravesical mitomycin C (MMC) or gemcitabine (investigator's choice) once weekly for 4 to 6 induction doses followed by a maintenance phase for a minimum of 6 months and up to 1 year.

Interventions

TAR-210

TAR-210 will be administered intravesically.

Gemcitabine

Gemcitabine will be administered intravesically.

MMC

MMC will be administered intravesically.

Primary outcome measure

Disease Free Survival (DFS) [ Time Frame: From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months) ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210 Participate-In-This-Study@its.jnj.com

Locations

Genesis Research LLC

Recruiting

Los Alamitos, California, United States, 90720

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

University of California Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Genesis Research

Recruiting

San Diego, California, United States, 92123

University of Colorado Cancer Center Anschultz Cancer Pavilion

Recruiting

Aurora, Colorado, United States, 80045

Colorado Clinical Research

Recruiting

Lakewood, Colorado, United States, 80228

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Wichita Urology Group

Recruiting

Wichita, Kansas, United States, 67226

Ochsner Health System

Recruiting

New Orleans, Louisiana, United States, 70121-2429

Brigham And Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Comprehensive Urology

Recruiting

Royal Oak, Michigan, United States, 48073

Specialty Clinical Research of St Louis

Recruiting

St Louis, Missouri, United States, 63141

The Urology Center, PC

Recruiting

Omaha, Nebraska, United States, 68114

Cancer Institute Of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Integrated Medical Professionals

Recruiting

New York, New York, United States, 10016

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Associated Medical Professionals of Ny

Recruiting

Syracuse, New York, United States, 13210

SUNY Upstate Med Univ

Recruiting

Syracuse, New York, United States, 13210

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Associated Urologists of North Carolina

Recruiting

Raleigh, North Carolina, United States, 27612

MidLantic Urology

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Keystone Urology Specialists

Recruiting

Lancaster, Pennsylvania, United States, 17604

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

The Conrad Pearson Clinic

Recruiting

Germantown, Tennessee, United States, 38138

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Urology Associates

Recruiting

Nashville, Tennessee, United States, 37209

Urology Austin

Recruiting

Austin, Texas, United States, 78745

Urology Clinics of North Texas

Recruiting

Dallas, Texas, United States, 75231

UT Southwestern

Recruiting

Dallas, Texas, United States, 75390

Houston Metro Urology

Recruiting

Houston, Texas, United States, 77027

Spokane Urology

Recruiting

Spokane, Washington, United States, 99202

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2025-12-19.