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 with a specific type of bladder cancer called urothelial carcinoma, confirmed by a tissue sample taken within the last 120 days, and classified as high grade Ta, high grade T1, or carcinoma in situ (CIS — a very early stage confined to the bladder lining).
• The cancer must be mainly urothelial in type; certain other subtypes are allowed as long as urothelial cancer makes up the majority, but pure squamous cell carcinoma or pure adenocarcinoma without any urothelial component are not allowed, and any neuroendocrine component (such as small cell or large cell) is not allowed.
• All visible tumour growths must have been surgically removed (via a procedure called TURBT) within the 90 days before joining the trial (some residual CIS is permitted); if the treating urologist did not perform that surgery, they must perform a camera examination of the bladder within 45 days before joining to confirm no visible growths remain.
• People with high grade T1 disease must have had a second TURBT procedure (called a restaging TURBT) within 90 days before joining, even if that second procedure found no remaining cancer.
• People whose bladder cancer has come back at a high grade within 24 months of their last BCG treatment (a type of bladder therapy), but whose disease does not meet the definition of being fully "BCG unresponsive" (confirm specific timing criteria with the trial site).
• More than one prior course of BCG treatment is allowed, as long as the disease does not currently meet the definition of BCG-unresponsive.
• Prior treatment with chemotherapy placed directly into the bladder (such as gemcitabine alone or combined with docetaxel, or gemcitabine delivered via a device system) is allowed.
• Prior treatment with other bladder or systemic therapies — including immunotherapy drugs such as pembrolizumab or other checkpoint inhibitors, or other approved bladder cancer treatments — is allowed.
• People who are living with HIV and are on effective treatment with an undetectable viral load within the past 6 months may be eligible.
• People aged 18 or older.
• People who have had, or currently have, another type of cancer whose treatment or natural course is unlikely to affect the safety or results of this trial may be eligible.
• People with a history of upper urinary tract urothelial cancer may be eligible, as long as it was non-muscle-invasive, was fully treated with surgery, and follow-up imaging shows no remaining upper tract disease.
• People with a history of, or current, non-invasive urothelial cancer of the prostatic urethra may be eligible, as long as a specific surgical procedure (TURP) has been performed before joining and there is no evidence of deeper tissue invasion.
• People who are not pregnant and not breastfeeding; those who could become pregnant must have a blood or urine pregnancy test within 14 days before joining (confirm specific requirements with the trial site).

Who may not be able to join:

• People whose bladder cancer has grown into the muscle wall of the bladder or beyond, or has spread to other parts of the body, based on imaging (CT scan or MRI) taken within the last 120 days.
• People whose disease meets the definition of BCG-unresponsive disease — for example, cancer that persisted or came back within certain short timeframes after a full course of BCG treatment (confirm specific timeframe criteria with the trial site).
• People who previously had to stop BCG treatment or any other bladder therapy early because of intolerable side effects.
• People whose bladder does not function well enough to be likely to tolerate further treatments placed directly into the bladder.
• People who are currently pregnant or breastfeeding.

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