Phase 3 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:

• People who are willing to take part and have signed a consent form agreeing to participate
• People aged 18 to 75 years (any gender) with a life expectancy of at least 2 years
• People who have been diagnosed through laboratory testing with a type of bladder cancer (non-muscle-invasive bladder urothelial carcinoma) that has not grown into the bladder muscle, and whose cancer tissue tests positive for a protein called PD-L1, and who are assessed as having a medium to high risk of the cancer coming back or getting worse
• People who are reasonably active and able to carry out daily activities, as measured by a standard medical score (ECOG score of 0–2)
• People who have completed a set of required health checks — including blood tests, heart trace (ECG), ultrasound, pelvic scan, and tissue testing — and who have no medical reasons preventing surgery

Who may not be able to join:

• People with a weakened immune system (such as those with AIDS), those currently taking medicines that suppress the immune system, those with an allergy to BCG (a type of treatment), those with a fever or active infection including active tuberculosis, or those with serious heart, blood vessel, or kidney disease
• People who have another cancer in the urinary or reproductive system, or cancer in any other part of the body
• People whose bladder cancer has grown into the bladder muscle (stage T2 or higher)
• People who have had chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (not including a single bladder wash-out treatment given immediately after surgery)
• Women who are pregnant or breastfeeding, women of childbearing age who are not using effective contraception, or anyone (including male participants whose partners could become pregnant) who is planning to conceive during the trial
• People where the surgeon suspects the bladder wall may have been accidentally punctured during surgery
• People with visible blood in the urine before joining, or where there is concern that surgical wounds or the bladder lining have not fully healed
• People with a severely narrowed urethra that prevents a bladder camera examination (cystoscopy), a history of a shrunken bladder, or a bladder that can hold less than 100mL of fluid
• People with active bladder inflammation (cystitis), or those who have had other bladder treatments and have significant bladder irritation that could affect the trial results
• People with serious mental health conditions, or serious problems with blood clotting, liver or kidney function, or blood cell production that would make surgery unsafe
• People who have taken part in another drug clinical trial within the 3 months before joining
• People with a known or suspected dependence on opioid medications or alcohol
• People with any other condition that the trial doctor believes could increase risk or affect how the trial is carried out (confirm with trial site)

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