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A Study of TAR-210 for High-Risk Bladder Cancer

This study is looking at a new treatment called TAR-210 for high-risk non-muscle-invasive bladder cancer (HR-NMIBC). This is a type of bladder cancer that has not spread into the muscle of the bladder. The study wants to see if TAR-210 is better at preventing the cancer from returning or getting worse compared to standard chemotherapy treatments like Mitomycin C or Gemcitabine. You might be able to join if you are 18 or older, have this specific type of bladder cancer, and your cancer has a certain genetic change called an FGFR mutation or fusion. The study is currently unclear on its recruitment status and plans to enroll about 220 people.

Study design
This study plans to enroll 220 participants. It compares TAR-210 to standard 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 disease-free survival for up to 5 years.

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

NCT06919965

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~220 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:TAR-210Mitomycin CGemcitabine

At a glance

Recruiting sites
111 of 113 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-free Survival (DFS)
Measured over Up to 5 years

Conditions

Non-Muscle Invasive Bladder Neoplasms

Explore related trials

Bladder CarcinomaFibroblast Growth Factor Receptor Family

NCT06919965

Where you'd take part

This study runs at 113 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Academic Urology and Urogynecology of Arizona

    Sun City, Arizonano site contact published

    Recruiting

  • Advanced Urology Institute

    Largo, Floridano site contact published

    Recruiting

  • Algemeen Ziekenhuis Delta

    Roeselare, Belgiumno site contact published

    Recruiting

  • Aou San Luigi Gonzaga

    Sanatorio San Luigi, Italyno site contact published

    Recruiting

  • Associated Medical Professionals

    Syracuse, New Yorkno site contact published

    Recruiting

  • Associated Urological Specialists

    Chicago Ridge, Illinoisno site contact published

    Recruiting

  • ASST Spedali Civili Brescia

    Brescia, Italyno site contact published

    Recruiting

  • Athens Medical Center S A Interbalkan Medical Center of Thessaloniki

    Thessaloniki, Greeceno 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

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

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

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Eligibility criteria

Inclusion

Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded
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
All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC
Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade \>= 2 toxicity requiring BCG discontinuation (BCG intolerant population)
Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2
Must be ineligible for or refusing radical cystectomy (RC)

Exclusion

Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is \[i.e.\], T2, T3, T4, N+, and/or M+)
Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer (\[N0, M0\] with a Gleason score less than or equal to \[\<=\] 7a, treated locally only \[radical prostatectomy/radiation therapy/focal treatment\]) and other malignancy that is considered at minimal risk of recurrence
Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210
A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\>) 4,000 milliliters (mL)
Indwelling catheters are not permitted; however, intermittent catheterization is acceptable

What this trial measures

  • Disease-free Survival (DFS)Up to 5 years

    DFS is measured as the time from randomization to the date of the first recurrence of HR-NMIBC (high-grade Ta, any T1 or carcinoma in situ \[CIS\]), progression, or death due to any cause, whichever occurs first.