Phase 2 Bladder Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For Parts 1–3:

• People diagnosed with bladder cancer that has grown into the muscle wall, or bladder cancer that has come back and has not grown into the muscle wall
• For certain groups in the trial: People whose tumor has a specific genetic change (called an FGFR mutation or fusion), confirmed by approved laboratory testing
• For Groups 1 and 2: People who have previously received a treatment called BCG, or people who have never received BCG because it was not available in their area in the past two years and is still unavailable (people who had to stop BCG early due to side effects may still be eligible)
• For Group 1 only: People who have declined or are not medically suitable for surgery to remove the bladder (called radical cystectomy)
• For Groups 2 and 4: People who are willing and medically suitable for bladder removal surgery

For Part 4:

• People with a confirmed diagnosis of a specific type of returning, lower-risk, non-muscle-invasive bladder cancer (called intermediate-risk Ta low grade tumors)
• People who have not yet had their visible tumor fully removed or destroyed before joining (a small partial biopsy is acceptable, as long as the remaining tumor is at least 5mm in size)
• People who are able to provide tissue and urine samples for genetic testing related to the FGFR gene
• People who have or have had a second, separate cancer, where that cancer or its treatment is unlikely to affect the trial's results

Who may not be able to join:

For Parts 1–3:

• People whose bladder cancer has spread beyond the bladder to areas such as the urethra, ureter, or kidney (renal pelvis)
• People who have previously been treated with a type of drug called an FGFR inhibitor
• People who received radiation therapy to the pelvic area within the last 6 months, or people who received it more than 6 months ago but show signs of radiation-related bladder damage on examination
• People whose bladder or urethral anatomy may make it unsafe to use the specific drug delivery device used in this trial, in the opinion of the treating doctor
• People who have a permanent urinary catheter in place (though people who use a catheter only occasionally may still be eligible)

For Part 4:

• People who have ever been diagnosed with a higher-risk or more advanced form of bladder cancer — unless the high-grade diagnosis was 5 or more years ago and there is documented evidence of only low-grade disease since then
• People with known allergies or sensitivities to any ingredient in the study treatment
• People who are being diagnosed with this type of bladder cancer for the very first time (rather than having a recurrence)
• People who have received another experimental bladder cancer treatment after their most recent bladder tumor surgery, or who are currently participating in another investigational study
• People with evidence of a hole or tear in the bladder wall, confirmed by examination or imaging

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