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:

• You are willing to take part voluntarily and can sign a consent form after being told about the study
• You are 18 years old or older (any gender)
• You are reasonably active and able to care for yourself, with only limited restrictions on daily activities (confirm with trial site)
• Your doctor expects you to live for at least 2 more years
• You have been diagnosed with high-risk non-muscle-invasive bladder cancer (an early-stage form of bladder cancer that has not spread into the bladder muscle), confirmed by a tissue sample
• A bladder examination within 6 weeks before starting the study showed that the cancer was fully removed, or that only a very early flat form of cancer remains; if your cancer was at a specific early stage (T1), the tissue sample must show bladder muscle was present
• You are not able to have, or do not wish to have, surgery to remove your bladder
• Your heart, liver, kidneys, and other organs are working well enough to take part
• You and your partner are willing to use reliable contraception during the study and for 3 months after it ends; if you are a woman of childbearing age who has not had sterilisation surgery, you must have a negative pregnancy blood test within 7 days before starting and must not be breastfeeding

Who may not be able to join:

• You had surgery or radiation treatment for bladder cancer within the 2 weeks before starting the study
• You previously received certain bladder treatments (such as chemotherapy directly into the bladder, immune checkpoint inhibitor drugs, or other experimental bladder cancer treatments) and your cancer did not get worse before joining this study (confirm with trial site)
• You are currently in another clinical trial, or finished one less than 4 weeks ago
• Scans or examinations during screening found cancer in your upper urinary tract, urethra/prostate area, or you have had another type of cancer in the past 5 years
• You have had active tuberculosis (TB) in the past year
• You had a serious infection within the 4 weeks before starting, or you have had an unexplained fever above 38.5°C during the screening period
• You have a significant urinary tract infection or visible blood in your urine that raises safety concerns, as judged by the study doctor
• You previously had to stop BCG treatment (a common bladder cancer therapy) because of serious side effects such as blood poisoning, widespread infection, or inability to control urination
• You have taken immune-suppressing medications within the 2 weeks before starting (some low-dose or inhaled steroids may be allowed — confirm with trial site)
• You have active or past lung scarring/inflammation disease (interstitial lung disease)
• You have a history of significant heart or blood vessel disease (confirm with trial site)
• You have a history of a weakened immune system, including HIV, other immune conditions, an organ transplant, or current use of immune-suppressing drugs
• You have an active autoimmune disease (a condition where your immune system attacks your own body)
• You have active hepatitis B or hepatitis C with detectable virus levels in your blood
• You are known to be allergic or sensitive to the study drug, BCG, or any of their ingredients
• You have other serious physical or mental health conditions, abnormal test results, or any other reason the study doctor believes makes it unsafe or unsuitable for you to take part

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