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 trial.
• People who are 18 years of age or older at the time of signing the consent form.
• People with a life expectancy of more than 12 months.
• People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard cancer performance scale (confirm with trial site).
• People who have been diagnosed with muscle-invasive bladder cancer (specifically T2–T3 stage, with no spread to lymph nodes or other parts of the body), confirmed through a tissue sample. Some mixed cancer types are allowed if bladder-related cancer cells are present. Cancer originating in the upper urinary tract is not permitted.
• People who previously received BCG or other treatments delivered directly into the bladder for early-stage bladder cancer, provided that treatment finished at least 6 weeks before starting this trial, and only one course of such treatment was received.
• People who have no signs of cancer spread to other parts of the body, based on imaging scans.
• People whose kidney function and overall health meet the trial's specific criteria for receiving cisplatin (a type of chemotherapy) (confirm with trial site).
• People who have not previously received chemotherapy or immunotherapy as part of bladder cancer treatment.
• People who agree to undergo bladder procedures (TURBT) before and after treatment, as well as regular monitoring through bladder camera examinations, imaging scans, and urine tests, unless a doctor determines these are medically inappropriate.

Who may not be able to join:

• People who currently have invasive cancer in the upper urinary tract (such as the ureter or the part of the kidney that connects to the ureter). Note: People with a history of non-invasive upper tract cancer that has been fully treated, with follow-up tests showing no remaining disease, may still be eligible (confirm with trial site).
• People who have previously received certain types of immunotherapy drugs that work by targeting immune system "checkpoint" pathways (such as anti-PD-1, anti-PD-L1, or anti-CTLA4 drugs), or who have received cancer cell vaccines, cell-based therapies, or virus-based cancer treatments.
• People who have previously had radiation therapy directed at the bladder for bladder cancer.
• People who have previously received chemotherapy through the bloodstream specifically for muscle-invasive bladder cancer.
• People who are currently taking part in another clinical trial, or have done so within 4 weeks before starting this trial.
• People who have had a solid organ or bone marrow transplant.
• People who have had, or currently have, an autoimmune disease that required treatment with immune-suppressing medications within the past 2 years. Some conditions are not disqualifying, including vitiligo, childhood asthma that has fully resolved, an underactive thyroid managed with hormone replacement only, and mild psoriasis not requiring systemic treatment.
• People who have been diagnosed with an immune system deficiency, or who are taking steroid medications above a certain dose (more than 10mg per day of prednisone or equivalent) or other immune-suppressing medications within 14 days before the first dose. Inhaled or topical steroids, and certain low-dose replacement steroids, may be permitted in some circumstances (confirm with trial site).
• People who have a history of heart muscle inflammation (myocarditis).
• People who currently have another active cancer, other than common non-melanoma skin cancers.
• People who have a known history of, or current signs of, scarring or inflammation of the lung tissue (interstitial lung disease or non-infectious pneumonitis).
• People who currently have an active infection that requires treatment through the bloodstream (such as intravenous antibiotics).
• People who have had a significant local or widespread infection (such as a serious skin infection, pneumonia, or blood infection) requiring antibiotic treatment within 2 weeks before the first trial dose.
• People who have any condition, ongoing treatment, or abnormal test result that the treating doctor believes could interfere with the trial results or make participation not in the person's best interest — including people who require dialysis.
• People with known mental health conditions or substance use disorders that would make it difficult to follow the trial's requirements.
• People with uncontrolled HIV, hepatitis B, or hepatitis C infection, or an immune deficiency linked to a long-term infection.
• People who are pregnant or currently breastfeeding.

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