Comparing TAR-210 to standard chemotherapy for bladder cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of TAR-210 in improving disease-free survival compared to standard intravesical chemotherapy options for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC). Participants will be randomly assigned to receive either TAR-210 or the investigator's choice of chemotherapy, which may include Gemcitabine or Mitomycin C (MMC). The study will involve multiple cystoscopies and assessments to monitor treatment outcomes and recurrence rates over time.

Why it matters

Who can join: the full rules

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

Where it's running

• Medizinische Universitaet Graz
  Graz, Austria Recruiting
• Medizinische Universitat Innsbruck
  Innsbruck, Austria Recruiting
• Medical University Vienna MUV
  Leopoldsdorf (Wien), Austria Recruiting
• Ordensklinikum Linz GmbH Elisabethinen
  Linz, Austria Recruiting
• Universitaetsklinikum Salzburg Landeskrankenhaus
  Salzburg, Austria Recruiting
• AZORG campus Aalst Moorselbaan
  Aalst, Belgium Recruiting

+143 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Real-world outcomes of TAR-200 for people with non-muscle invasive bladder cancer in the United States

  This project will see if TAR-200 helps people with non-muscle invasive bladder cancer stay disease-free longer after their first insertion during routine care in the U.S.

  Recruiting at 23 sites Janssen Research & Development, LLC · Birmingham, Alabama and 22 other locations · NCT07309445

• TAR-210 versus intravesical chemotherapy for high-risk non-muscle-invasive bladder cancer

  This trial will test whether TAR-210 prevents cancer recurrence better than standard bladder instillation chemotherapy (mitomycin C or gemcitabine) in people with high-risk non-muscle-invasive bladder cancer who have FGFR mutations or fusions.

  Recruiting at 111 sites Phase 3 Janssen Research & Development, LLC · Sun City, Arizona and 114 other locations · NCT06919965

• New treatment for high-risk non-muscle invasive bladder cancer

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• Erdafitinib with or without Cetrelimab for muscle-invasive bladder cancer

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• Tracking quality of life and relapses in bladder cancer patients after surgery

  This study is tracking how bladder cancer patients feel and whether their cancer comes back after surgery over the next 10 years.

  Recruiting IRCCS San Raffaele · Milan, MI · NCT06167356

• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.