Phase 2 Bladder Cancer Trial, Recruiting NCT06488222 Sponsor: University of Florida Condition: Bladder Cancer
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Phase 2 Bladder Cancer Trial, Recruiting

NCT06488222
Recruiting Phase 2

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 must be 18 years of age or older.
  • You have been diagnosed with a specific type of low-grade bladder cancer (called low-grade Ta urothelial carcinoma), which is either returning after a previous occurrence, a single tumor larger than 3 cm, or multiple tumors present at the same time (up to 10% high-grade cells are allowed).
  • You are generally able to carry out daily activities, with only mild limitations at most (confirm with trial site).
  • Scans or imaging have shown no signs of cancer in the upper urinary tract (kidneys or ureters).
  • A bladder examination (cystoscopy) has shown no cancer in the urethra (the tube that carries urine out of the body).
  • A bladder examination within the past 60 days has shown no visible tumors remaining.
  • Your blood test shows a healthy enough level of white blood cells (neutrophils ≥ 1,500 cells/mm³).
  • Your blood test shows a healthy enough level of platelets (> 100,000 cells/mm³).
  • If you have or have had another type of cancer, you may still be eligible if your doctor determines it would not interfere with this trial.
  • If you are able to become pregnant, you must agree to use effective birth control during the study and for at least 6 months after the last dose of the study treatment.
  • If your partner can become pregnant, you must agree to use approved contraception during the study and for at least 3 months after the last dose of the study treatment.
  • You must be willing to sign a consent form and agree to follow all study procedures.

Who may not be able to join:

  • You have a history of high-grade bladder cancer or high-grade cancer in your upper urinary tract.
  • You have previously been treated with a bladder treatment called BCG (a common immunotherapy given directly into the bladder).
  • Your bladder cancer is a specific type called pure squamous cell carcinoma or adenocarcinoma.
  • Your cancer includes any component of a type called neuroendocrine carcinoma.
  • You have a physical condition that makes it impossible to insert a urinary catheter.
  • Your bladder is too small to receive treatment delivered directly into the bladder, as determined by your urologist.
  • You are able to become pregnant but are unwilling or unable to use acceptable birth control for the full study period and for at least 6 months after the last dose.
  • You are currently pregnant or breastfeeding.
  • You have another serious health condition that your doctor believes could make the treatment unsafe or affect the study results.
  • You have received a vaccine containing a live virus within 30 days before starting the trial (for example, the nasal spray flu vaccine FluMist — note that most standard flu shots do not contain live virus and may be acceptable; confirm with trial site).
  • You are currently in prison, held in a facility against your will, or are being detained for treatment of a mental health or physical health condition.

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 26 July 2026
Phase 2: approximately ~30% 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: Paul Crispen, MD, University of Florida

Phone: 352-294-5018

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 2
Registry
ClinicalTrials.gov
Start date
5 November 2024
Est. completion
1 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Recurrence free survival

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: 26 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