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:

• You are willing to sign a consent form and are able to follow all steps of the trial from start to finish.
• You are between 18 and 75 years old (any gender).
• Your general health and ability to carry out daily activities is rated as good or fully active (confirm with trial site).
• You have been diagnosed with bladder cancer that has not grown into the muscle layer of the bladder, confirmed by scans and tissue testing.
• Your bladder cancer falls into a specific "high-risk" category based on 2024 medical guidelines, which takes into account the type, stage, and certain risk factors such as being over 70 years old, having multiple tumours, or having a tumour larger than 3cm (confirm with trial site).
• You are willing to provide tissue samples from a previous bladder biopsy or surgery (such as stored tissue blocks or slides).
• At least 6 weeks have passed since your last cancer treatment (such as chemotherapy, radiotherapy, or immunotherapy).
• Your blood counts, kidney function, and liver function results fall within acceptable ranges as set by the trial (confirm with trial site for specific values).
• If you are male, you agree to use effective contraception during treatment and for at least 180 days after your last treatment, and agree not to donate sperm during this time.
• If you are a woman who could become pregnant, you have a negative pregnancy blood test within 72 hours before starting treatment and agree to use effective contraception during treatment and for at least 180 days after treatment ends.

Who may not be able to join:

• Your cancer started in the upper part of the urinary tract (kidney or ureter) rather than the bladder.
• You have been diagnosed with another type of cancer in the last 5 years, unless it was a specific low-risk, well-treated cancer such as certain early-stage prostate cancers, fully treated cervical cancer in situ, certain treated skin cancers, or treated early-stage breast cancer in situ (confirm with trial site).
• You have an active autoimmune disease that has required long-term treatment with steroids or immune-suppressing medicines in the past two years (hormone replacement therapies for other conditions are not included in this restriction).
• You are expected to have major surgery during the trial, or you had major surgery within the past 4 weeks and have not fully recovered.
• Side effects from previous cancer treatments have not sufficiently resolved (confirm with trial site for specific grade levels).
• You are HIV-positive or have a history of HIV or other immune deficiency diseases.
• You have active hepatitis B or hepatitis C requiring long-term antiviral treatment, based on specific blood test results (confirm with trial site).
• You have serious ongoing conditions such as uncontrolled heart, brain, or blood vessel disease, or uncontrolled diabetes.
• You have had an organ transplant or stem cell transplant in the past.
• You have significant heart failure (classified as a serious level by your doctor).
• You have serious lung disease that causes breathlessness at rest or with light activity, or requires oxygen.
• You have another health condition that the trial doctor believes would make it unsafe for you to take part or would interfere with the trial results.
• You have a serious active infection at the time of starting the trial.
• You have alcohol dependence or a history of drug or substance misuse in the past year.
• You have a known neurological or psychiatric condition such as epilepsy, dementia, or a nerve disorder that affects your daily functioning.
• You are pregnant, breastfeeding, or planning to become pregnant during the trial.
• You have a known allergy or intolerance to mitomycin (the medicine used in this trial) or any of its ingredients.
• The trial doctor considers you unsuitable for the trial for any other reason.

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