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 between 18 and 75 years old.
• People who have been diagnosed with high-risk or very high-risk bladder cancer that has not grown into the muscle wall of the bladder, confirmed by a tissue sample taken during a surgical procedure or biopsy.
• People who have not previously received any immunotherapy treatments targeting specific immune pathways (such as PD-1, PD-L1, PD-L2, or CTLA-4 blockers), or the bladder cancer treatment known as BCG.
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard medical scale (confirm with trial site).
• People whose blood counts, liver function, and kidney function meet specific minimum levels on blood tests taken within the two weeks before joining (confirm with trial site for exact values required).
• Women who could become pregnant must have a negative pregnancy test within 7 days before joining, and both male and female participants must agree to use effective contraception during the trial and for at least 6 months after the last dose.
• People who are willing to give written consent to participate, follow the study requirements, and attend follow-up appointments.

Who may not be able to join:

• People who have or have had bladder cancer that has grown into the muscle wall, spread to other parts of the body, or is also present in the upper urinary tract.
• People who have had bladder surgery other than the standard procedure to remove bladder tumours (TURBT) or a bladder biopsy.
• People who have received other systemic cancer treatments or certain immune-modifying medicines within 28 days before joining.
• People who have had a serious active infection requiring antibiotic, antifungal, or antiviral treatment within 14 days before joining.
• People who have had major surgery or a significant injury within 28 days before joining.
• People who have received a live vaccine within 28 days before joining.
• People who have used Chinese herbal medicine or traditional Chinese medicine products intended to control cancer within 14 days before joining.
• People who have taken steroid medicines that affect the whole body within 4 weeks before joining.
• People with active autoimmune diseases that require ongoing treatment, or other conditions that require long-term use of high-dose steroids or immune-suppressing medicines.
• People with certain uncontrolled health conditions — such as abnormal electrolyte levels, low blood protein, lung disease, or poorly controlled diabetes, high blood pressure, or heart conditions — that the trial doctor believes could interfere with treatment.
• People with active hepatitis B or C infections meeting specific virus level thresholds (confirm with trial site for exact values).
• People with a known history of HIV infection or AIDS.
• People who have had an organ transplant or stem cell transplant that required immune-suppressing medication (some transplants, such as corneal or hair transplants, may not apply — confirm with trial site).
• People with a known allergy to any of the medicines used in this trial.
• People who are currently taking part in another clinical trial.
• People with a history of other cancers, unless the cancer was fully treated with no return for more than 3 years, or was an early-stage skin cancer or a fully removed localised cancer considered cured (confirm with trial site).
• People with active cancer spread to the brain or the membranes surrounding the brain or spinal cord.
• People whom the trial doctor considers unsuitable for participation for any other reason.

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