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 who are willing and able to sign a written consent form for the study.
• People who are older than 18 years of age at the time of signing the consent form.
• People who have been diagnosed with a specific type of non-muscle-invasive bladder cancer (called carcinoma in situ, or CIS, with or without certain other early-stage bladder tumours), confirmed by biopsy using a standard international classification system, with the most recent bladder examination and/or tumour removal performed within 12 weeks of the study procedure.
• People who either cannot tolerate the BCG treatment or whose bladder cancer has stopped responding to BCG, meaning they received most of an initial BCG course plus most of either a maintenance course or a second full course.
• People who are not able to have their bladder surgically removed for medical reasons, or who have chosen not to have that surgery.
• People with a general health and activity level rated 0 to 2 on a standard medical scale (meaning people who are fully active, have some limitations but can care for themselves, or are up and about more than half of waking hours) (confirm with trial site).
• People whose bladder works well enough to hold the study drug inside for at least 60 minutes.
• People who are available for the full duration of the study, including follow-up visits over approximately 15 months.
• Women who could become pregnant must have a negative pregnancy test during the screening visit, confirmed before the study procedure.
• Women who could become pregnant must agree to use two forms of contraception, be surgically sterile, or avoid heterosexual activity for two weeks after the study procedure.

Who may not be able to join:

• People who have had, or currently have, bladder cancer that has grown into the bladder muscle or spread to other parts of the body.
• People who have the same type of bladder cancer present outside the bladder itself (such as in the urethra, ureters, kidney, or prostate), confirmed by scans or biopsy within 3 months before enrolment — or if those checks were done more than 3 months ago, they must be repeated before enrolment can be considered.
• People who currently have significant visible blood in their urine.
• People who have another cancer that is growing or currently being treated — with certain exceptions, such as some skin cancers that have been treated, early-stage cervical cancer, or certain low-risk prostate cancers meeting specific criteria (confirm with trial site).
• People who have any health condition, past surgery, ongoing treatment, or abnormal test result that, in the doctor's opinion, could affect study results or would not be in the person's best interest.
• People who are currently receiving medications that are not permitted during this study (confirm with trial site for the specific list).
• People who have taken part in another clinical trial involving an experimental treatment or device within 1 month before the first study procedure.
• People who have received a chemotherapy treatment directly into the bladder within 1 month before the first study procedure (a single dose given immediately after tumour removal surgery is not counted as a treatment).
• People who have an active infection requiring treatment — including an ongoing urinary tract infection that has not cleared up before the procedure.
• People who have any medical reason that prevents them from safely receiving general or spinal anaesthesia.
• People who are pregnant or breastfeeding at any point from the screening visit through to two weeks after the last study procedure.

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