Phase 1 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, can sign a consent form, and are able to follow the study schedule and requirements.
• You are 18 years old or older at the time of signing the consent form.
• You are reasonably active and able to care for yourself, with little or no limitation in daily activities (confirm with trial site what this means for your situation).
• You have bladder cancer (a type called urothelial carcinoma) that was not fully removed by a procedure called TURBT, and scans show the cancer is at a certain stage — it has grown into the bladder muscle or nearby tissue but has not spread to lymph nodes or other parts of the body.
• In the 30 days before starting treatment, you had a bacterial infection serious enough to require antibiotic treatment, confirmed by symptoms, blood tests, urine tests, imaging, or lab cultures.
• Your blood counts, liver, and kidney functions are at acceptable levels, tested within 14 days before joining the trial.
• Your doctor considers you suitable to receive a chemotherapy drug called cisplatin, OR you meet specific medical criteria that would normally make cisplatin unsuitable for you (confirm with trial site).
• If you are a woman who could become pregnant, you agree to use highly effective contraception during the study and for at least 120 days after your last dose of treatment, and you have a negative pregnancy test within 7 days before joining.
• If you are a man who has not been sterilised, you agree to use highly effective contraception for the same period.

Who may not be able to join:

• You have previously received certain immune checkpoint or T-cell targeting treatments (such as PD-1, PD-L1, or CTLA-4 inhibitors).
• You have received systemic (whole-body) cancer treatment or certain immune-boosting drugs within the last 28 days.
• You have previously had radiotherapy directed at the bladder.
• You have had certain prior cancer drug treatments — unless it has been at least 12 months since your last systemic chemotherapy, or bladder-only (intravesical) treatment was finished at least 1 week ago.
• You have had major surgery or a serious injury within the last 28 days (note: TURBT and placement of a vascular access line do not count as major surgery).
• You have received a live vaccine within the last 28 days (standard flu shots are usually fine, but the nasal spray flu vaccine is not permitted).
• You have an active autoimmune condition that requires ongoing systemic treatment and could interfere with the study treatment.
• You are taking high-dose steroids or other immune-suppressing medications long-term in a way that could interfere with the study treatment.
• You have significant health problems that could affect treatment, such as serious imbalances in body salts, lung disease, uncontrolled diabetes, uncontrolled high blood pressure, or serious heart problems (such as a heart attack or severe heart failure within the past 6 months).
• You have an untreated or poorly controlled hepatitis B (HBV) infection with a high level of virus in your blood (confirm with trial site for exact thresholds).
• You have an active hepatitis C (HCV) infection with detectable virus in your blood.
• You have a weakened immune system due to HIV, another immune deficiency condition, or you have previously received an organ or stem cell transplant.
• You have a known allergy to monoclonal antibody medicines.
• You have a known allergy to any of the drugs or ingredients used in this study.
• You still have significant side effects from a previous treatment that have not resolved or returned to a stable level.
• You have any medical condition or substance use issue that could make it unsafe for you to participate or make it hard to interpret the study results.

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