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A Study of TAR-210 for Bladder Cancer

This study is testing a new treatment called TAR-210 for people with a type of bladder cancer called intermediate-risk non-muscle invasive bladder cancer (NMIBC). Researchers want to see if TAR-210 is better at preventing the cancer from coming back compared to standard treatments like Gemcitabine or MMC, which are given directly into the bladder. You might be able to join if you are 18 or older and have a recent diagnosis of this type of bladder cancer. The study will follow participants for about 4 years and 2 months to see how long they remain free of disease. The study aims to enroll 641 participants.

Study design
This interventional study plans to enroll 641 participants. It compares TAR-210 to standard intravesical chemotherapy treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 4 years and 2 months to track disease-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06319820

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~641 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:TAR-210GemcitabineMMC

At a glance

Recruiting sites
83 of 193 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease Free Survival (DFS)
Measured over From randomization to the date of the first documented recurrence, disease progression or death (approximately 4 years and 2 months)

Conditions

Non-Muscle Invasive Bladder Neoplasms

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NCT06319820

Where you'd take part

This study runs at 193 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A.O.Citta della Salute e della Scienza di Torino

    Torino, Italyno site contact published

    Recruiting

  • Aarhus University Hospital

    Aarhus, Denmarkno site contact published

    Recruiting

  • APHP - Hopital Bichat - Claude Bernard

    Paris, Franceno site contact published

    Recruiting

  • ASST Spedali Civili Brescia

    Brescia, Italyno site contact published

    Recruiting

  • AZ Maria Middelares

    Ghent, Belgiumno site contact published

    Recruiting

  • AZ Sint-Jan

    Bruges, Belgiumno site contact published

    Recruiting

  • AZORG campus Aalst Moorselbaan

    Aalst, Belgiumno site contact published

    Recruiting

  • Charing Cross Hospital

    London, United Kingdomno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Johnson & Johnson Enterprise Innovation Inc. Clinical Trial · STUDY_DIRECTOR · Johnson & Johnson Enterprise Innovation Inc.

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

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

    DFS is measured as the time from randomization to the date of the first documented recurrence of Ta non-muscle invasive bladder cancer (NMIBC) of any grade, disease progression, or death due to any cause, whichever occurs first.