Phase 3 Bladder Cancer Trial, Recruiting

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

Who might be able to join this trial:

• People who have been diagnosed by a pathologist with a specific type of early-stage bladder cancer called high-grade non-muscle-invasive bladder cancer (HR-NMIBC) that is papillary (wart-like growths) only, with no flat lesions (called CIS). Certain mixed tumour types may be allowed if the main cell type is urothelial, but some rare variants are not permitted.
• People whose bladder cancer has a specific genetic change (a mutation or fusion) in a gene called FGFR, detected through a urine or tissue test.
• People who have had all visible tumour completely removed before joining the trial, and whose urine test does not show signs of high-grade cancer cells at the time of joining.
• People who fall into one of three groups based on their history with BCG treatment: those whose cancer came back or did not respond after receiving a full or near-full course of BCG (with or without maintenance doses); those who received BCG and had cancer return within 12 months of their last BCG dose; or those who had to stop BCG early (after at least 5 doses) due to significant side effects.
• People who have a physical performance level rated 0, 1, or 2 on a standard medical scale, meaning they are fully active, have some limitations but can care for themselves, or are up and about more than half of waking hours.
• People who are not able to have, or who have chosen not to have, surgery to remove the bladder (radical cystectomy).

Who may not be able to join:

• People who have or have had flat cancerous lesions in the bladder (called CIS) at any point since their current bladder cancer was diagnosed, or who have or have had bladder cancer that has grown into the bladder muscle or spread to other parts of the body.
• People who have another active cancer that has been progressing or required a change in treatment within the last 24 months (some exceptions apply for certain low-risk or previously treated cancers — confirm with trial site).
• People whose bladder or urethra has a physical feature that, in the treating doctor's judgement, could make it unsafe to insert, keep in place, or remove the trial device (called TAR-210).
• People who have a history of producing very large amounts of urine — more than 4,000 mL (about 4 litres) over a 24-hour period.
• People who have a permanent urinary catheter in place (though people who use a catheter only sometimes, when needed, may still be considered — confirm with trial site).

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