Phase 3 Bladder Cancer Trial, Recruiting NCT06319820 Sponsor: Janssen Research & Development, LLC Condition: Bladder Cancer
Back to Bladder Cancer

Phase 3 Bladder Cancer Trial, Recruiting

NCT06319820
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with a specific type of early-stage bladder cancer (non-muscle-invasive bladder cancer at intermediate risk), confirmed by a tissue sample taken within the last 90 days, meeting certain grade and risk factor criteria (confirm with trial site for exact details)
  • Your bladder cancer cells have a specific genetic change (in a gene called FGFR), detected through either a urine test or a tissue sample
  • You are willing to undergo all required study procedures, including multiple bladder examinations (cystoscopies) and any additional procedures to check if the cancer comes back or grows
  • All visible bladder tumour has been fully removed before joining the trial, and this has been confirmed by a bladder examination
  • You may have had or currently have a second, separate cancer, as long as it is unlikely to affect the trial results or your safety
  • You are generally able to carry out daily activities, or have only mild limitations (based on a standard health performance scale rated 0 to 2)

Who may not be able to join:

  • You have a known allergy or bad reaction to any of the study medications or their ingredients, including erdafitinib, the TAR-210 drug delivery device materials, catheter materials, mitomycin C (MMC), or gemcitabine
  • You have a physical feature of your bladder or urethra (such as a narrowing of the urethra) that could make it unsafe to insert, use, or remove the study device or a bladder catheter
  • You produce a very large amount of urine — more than 4,000 mL (about 4 litres) in 24 hours
  • You currently have a permanent urinary catheter in place (though using a catheter only when needed is acceptable)
  • You have had major surgery or a serious injury within the last 4 weeks and have not fully recovered (note: bladder tumour removal surgery does not count as major surgery for this purpose)
  • (For a specific part of the trial only) You have previously been diagnosed with bladder cancer of the same type at any point before your current diagnosis

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Johnson & Johnson Enterprise Innovation Inc. Clinical Trial, Johnson & Johnson Enterprise Innovation Inc.

Phone: 844-434-4210

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
18 April 2024
Est. completion
28 June 2028

Where this trial is recruiting

🇦🇷 Argentina 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany Hong Kong 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Disease Free Survival (DFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov