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 to take part, can give written consent, and are able to follow the study schedule and requirements.
• People aged 18 to 85 years old at the time of signing the consent form.
• People who have bladder cancer that remains after a surgical procedure to remove bladder tumours (TURBT), where the cancer has been confirmed by laboratory testing as a specific type called urothelial carcinoma, at a certain stage of spread (confirm with trial site for staging details). If the tumour is a mixed type, urothelial carcinoma must make up at least half of it.
• People who have tumour tissue samples and a pathology report available from their TURBT procedure.
• People whose tumour tests positive for a protein called HER2 at a level of 2+ or 3+ on a specific laboratory test.
• People who have not previously received any treatment that targets HER2, and have not previously received a type of cancer immunotherapy called PD-(L)1 therapy.
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (meaning they are fully active to capable of limited self-care) (confirm with trial site).
• People whose blood tests, taken within 14 days before joining, show that their blood counts, liver function, and blood clotting levels are within acceptable ranges set by the trial.
• Women who could become pregnant must have a negative pregnancy test within 7 days before joining, and must agree to use highly effective contraception during the study and for at least 120 days after the last dose of study treatment.
• Men who have not been surgically sterilised must agree to use highly effective contraception during the study and for at least 120 days after the last dose of study treatment.

Who may not be able to join:

• Women who are pregnant or breastfeeding.
• People who have an active, uncontrolled infection that requires treatment.
• People who have been diagnosed with another cancer within the past 5 years.
• People who have had major surgery or a serious physical injury within 28 days before joining (note: port or line placement and TURBT do not count as major surgery for this criterion).
• People who have previously had radiation therapy to the bladder for bladder cancer.
• People with an active autoimmune disease (where the immune system attacks the body) that requires ongoing systemic treatment and that the trial doctor believes could affect the study treatment.
• People with certain recent or serious heart or blood vessel conditions, including: chest pain from the heart in the last 28 days, a blood clot in the lungs in the last 28 days, a heart attack in the last 6 months, a certain level of heart failure in the last 6 months, a serious irregular heartbeat in the last 6 months, a stroke in the last 6 months, an abnormal heart rhythm reading on an ECG above specified levels, or a heart pumping function below 50%.
• People with a history of a heart attack or stroke caused by a blockage within the past 6 months (confirm with trial site, as this may overlap with the cardiovascular criteria above).
• People with HIV infection, active syphilis, or active tuberculosis.
• People with an active hepatitis B or hepatitis C infection.
• People with a history of certain lung conditions, including scarring of the lung tissue, inflammation of the lung not caused by infection, or uncontrolled lung disease.
• People who are known to have a serious allergic reaction to any of the study drugs.
• People who are currently taking part in another interventional clinical trial (trials that are observational only, or where someone is only in a follow-up phase, may be acceptable — confirm with trial site).
• People who, in the trial doctor's judgement, have any other condition that would make participation unsuitable.

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