Phase 2 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 aged 18 to 80 years old.
• People who are able to give informed consent (agree to participate after being fully informed about the study).
• People who have been diagnosed with high-grade non-muscle-invasive bladder cancer (a type of bladder cancer that has not grown into the deeper muscle layer of the bladder), confirmed by a tissue sample (biopsy). This includes people whose cancer was still present after receiving at least 5 out of 6 doses of BCG treatment, as long as the cancer has not spread or worsened.
• People who are not suitable for, or who have chosen not to have, surgery to remove the bladder (radical cystectomy).
• People who are able to attend all appointments and visits for the full duration of the study.
• People whose doctor estimates they have a life expectancy of more than 2 years.
• People who are reasonably active and able to care for themselves, based on a standard health scale called the ECOG scale (a score of 2 or less, meaning someone can look after themselves even if they are not fully active).
• People who do not have cancer in the upper urinary tract (kidneys or ureters) or in the part of the urethra that runs through the prostate. This must be confirmed by a scan (such as a CT scan or MRI) done within 6 months of joining the study, if the doctor considers it necessary.
• People with low-risk prostate cancer being monitored (not treated) may be considered for the trial at the doctor's discretion, provided their PSA level is below 10 ng/dL, their Gleason score is 6, and their cancer is at an early clinical stage (cT1).
• Women who could become pregnant must use two approved forms of contraception during the study and for 1 month after the last study treatment, and must have a negative pregnancy test before starting. Women who have not had a period for at least 12 months (postmenopausal) or who have had surgery making them unable to become pregnant are also eligible.

Who may not be able to join:

• People whose cancer has grown into the deeper muscle layer of the bladder or has spread to other parts of the body (metastatic disease). This includes people whose biopsy shows features that increase the risk of spread, such as cancer cells found in blood or lymph vessels (lymphovascular invasion) or a specific aggressive pattern called micropapillary disease.
• People with T1 bladder cancer (cancer that has grown into the tissue just under the bladder lining) who also have a blockage of urine flow from the kidney (hydronephrosis) caused by the tumour — unless a procedure to relieve the blockage is already planned.
• People who are currently receiving systemic (whole-body) treatment for bladder cancer.
• People who currently have a urinary tract infection or bacterial inflammation of the bladder (though once this is successfully treated, eligibility may be reconsidered — confirm with trial site).
• People who have significantly abnormal liver or kidney function test results that cannot be explained.
• Women who are pregnant, breastfeeding, or who are not willing to use contraception throughout the study.
• People who have any other significant health condition or finding that the study doctor believes would make participation unsafe or unsuitable.
• People who have had another type of cancer in the past 5 years — with exceptions for certain treated skin cancers and a specific type of upper urinary tract cancer treated by kidney removal at least 24 months before joining, provided it had not spread beyond a certain stage (confirm with trial site).

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