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 willing to take part and able to sign a consent form agreeing to participate.
• You are between 18 and 80 years old at the time of signing the consent form.
• You are generally active and able to care for yourself, with only mild limitations on physical activity (confirm with trial site).
• You have been diagnosed with muscle-invasive bladder cancer confirmed by a tissue sample, with less than half of the sample showing an unusual cell type.
• Scans have confirmed your cancer has not spread to other parts of the body, and your cancer is locally advanced or has certain high-risk features (confirm with trial site).
• Your doctors have assessed that you are well enough to have surgery to remove your bladder and to receive a chemotherapy treatment that contains a drug called cisplatin.
• You are able to provide tumor tissue samples for testing.
• You are expected to live for at least 12 weeks.
• Your blood tests show that your blood cells, liver, kidneys, and heart are all working well enough to meet specific levels set by the trial (confirm with trial site for exact values).
• If you are a woman who could become pregnant, you have had a negative pregnancy test within 7 days before starting treatment and are willing to use reliable contraception during the study and for 180 days after your last dose.
• If you are a man whose partner could become pregnant, you are either surgically sterile or willing to use reliable contraception during the study and for 180 days after your last dose.
• You are able to follow the study schedule, attend visits, and complete all required procedures.

Who may not be able to join:

• You have previously had any systemic treatment for bladder cancer, such as radiotherapy, chemotherapy, targeted therapy, or immunotherapy (note: certain bladder wash treatments may be allowed — confirm with trial site).
• You have previously been treated with a type of immunotherapy drug called a PD-1/PD-L1 inhibitor, or a type of treatment called an antibody-drug conjugate (ADC).
• You have had another cancer in the past 3 years, unless it was a type that has been fully cured (such as certain skin cancers or early-stage cancers — confirm with trial site).
• You have an active autoimmune disease (where your immune system attacks your own body) that required treatment in the past 2 years, or you have taken high-dose steroid or immune-suppressing medications very recently.
• You have had a serious blood clot, heart attack, unstable chest pain, stroke, or similar heart or blood vessel problem within the past year.
• You have had major surgery in the past 28 days, or a bladder scope procedure or bladder wash treatment in the past 7 days.
• You have moderate or severe nerve damage causing weakness, numbness, or pain in your hands or feet.
• You have a serious dry eye condition, active eye inflammation, corneal ulcers, or another eye condition that may increase your risk of eye problems during the trial.
• You have certain active infections, including active hepatitis B, hepatitis C, HIV, active tuberculosis, or other infections currently requiring treatment.
• You have certain serious uncontrolled health conditions, such as severe lung disease, advanced heart failure, poorly controlled diabetes, poorly controlled high blood pressure, or a large build-up of fluid in the chest or abdomen.
• You have received a live vaccine in the past 28 days or plan to receive one during the trial.
• You have previously had a bone marrow transplant or an organ transplant from another person.
• You have taken certain medications that strongly affect how the body processes drugs (strong CYP3A4 inhibitors or inducers) within the past 14 days (confirm with trial site).
• You have a known serious allergy or intolerance to any of the study drugs or their ingredients.
• You have a substance use disorder or a mental health condition that may make it difficult to follow the study requirements.
• Your doctor has identified any other reason that makes participation unsuitable for you.

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