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 18 years of age or older
• You have been diagnosed with a specific type of bladder cancer (called high-grade transitional cell carcinoma) that has not grown into the bladder muscle, confirmed by a tissue sample
• Your bladder cancer has not responded to BCG treatment (a common bladder cancer therapy), and this has been confirmed by tissue testing
• After surgical removal of tumors (a procedure called TURBT), there is no remaining removable disease — though some surface-level cancer cells in the lining may still be present
• You are either unwilling to have your bladder surgically removed, or your doctor has determined that surgery is not suitable for you
• Your general health and activity level fall within an acceptable range (confirm with trial site)
• Your doctor expects you to live for at least 2 more years
• Your major organs (such as kidneys, liver, and heart) are functioning well enough to participate
• You are willing to give written consent and agree to follow all trial procedures and check-ups

Who may not be able to join:

• You have previously received certain immune-boosting therapies involving IL-2 or IL-15 (specific drug types — confirm with trial site)
• You received significant pelvic radiation therapy within the past 2 years
• You received any systemic (whole-body) treatment for your bladder cancer within the past 4 weeks
• You received any treatment directly into the bladder (intravesical therapy) within the past 4 weeks
• You had bladder surgery (such as TURBT) within the past 2 weeks
• You have a known allergy to the trial drug or similar types of treatments, or to BCG (confirm with trial site)
• You have been taking immune-suppressing medications at significant doses within the past 4 weeks (some low-dose exceptions may apply — confirm with trial site)
• You have previously had an organ transplant or bone marrow/stem cell transplant from another person
• You received a live virus vaccine within the past 4 weeks
• You previously had a severe or treatment-stopping immune-related side effect from an immunotherapy drug (some exceptions may apply — confirm with trial site)
• You have unresolved serious side effects from previous cancer treatments that have not sufficiently improved
• You have a history of bladder cancer that has grown into the muscle or spread to other parts of the body
• You have had tumors in your upper urinary tract (such as the kidneys or ureters) or in the urethral area near the prostate
• You have a known condition where urine flows backward from the bladder to the kidneys, or there is evidence of a hole in your bladder
• You currently have an active urinary tract infection
• You had to stop BCG treatment in the past due to serious reactions such as blood poisoning or serious infection
• You have complications from bladder surgery that would prevent treatment being placed directly into the bladder
• You produce an unusually large amount of urine each day (more than 4,000 mL in 24 hours)
• You have been diagnosed with another cancer within the past 2 years that is still active or required treatment
• You have an active autoimmune disease that requires immune-suppressing medication
• You have a history of serious lung damage or lung toxicity
• You have had active tuberculosis (TB) in the lungs within the past year, or a past TB infection that was not fully treated
• You have uncontrolled fluid build-up around your lungs, heart, or abdomen that requires frequent draining
• You have a significant history of serious heart disease
• You had major surgery within the past 4 weeks
• You have had a serious infection within the past 4 weeks
• You have ever had confirmed active Hepatitis B, Hepatitis C, HIV, or active tuberculosis
• You are currently pregnant or breastfeeding
• You have a known or suspected substance misuse problem (certain exceptions for medically prescribed medications may apply — confirm with trial site)
• Your doctor determines there is any other reason you would not be suitable for this trial

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