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 give written consent to participate.
• People aged 18 or older, of any gender.
• People who are not able to receive cisplatin-based chemotherapy, or who have chosen not to receive it, for one of these reasons: kidney function below a certain level, a moderate decline in physical functioning, significant hearing loss, significant nerve damage, or a personal decision to decline that type of chemotherapy.
• People who are medically suitable to undergo bladder surgery procedures (TURBT and radical cystectomy).
• People whose tumour tissue has tested positive for a protein called HER-2 (at a level of 1+ or higher) on a laboratory test.
• People who have at least one measurable tumour area, as defined by standard medical measurement guidelines (RECIST 1.1).
• People whose heart, blood, and organ function meet specific laboratory thresholds measured within 7 days before starting treatment — including heart pumping function of at least 50%, adequate blood counts, and liver and bilirubin levels within acceptable ranges.
• Women who could potentially become pregnant, and men whose partners could potentially become pregnant, must agree to use highly effective contraception during the trial.
• People who are willing to follow the trial's schedule, rules, and requirements.

Who may not be able to join:

• People with a known allergy or sensitivity to the study drug (an anti-HER2 antibody-drug combination) or to toripalimab (the immunotherapy used in the trial).
• People whose side effects from previous cancer treatment have not improved to a mild or resolved level (except for hair loss at a moderate level, which is permitted).
• People who have fluid build-up in the chest or abdomen that is causing symptoms and requires ongoing treatment.
• People who have had a major surgical procedure within 4 weeks before the planned start of the trial.
• People who have received a live virus vaccine within 4 weeks before the planned start of the trial.
• People with a currently active, known HIV or tuberculosis infection.
• People who have tested positive for certain hepatitis B or hepatitis C markers, including active hepatitis B virus in the blood.
• People who have any other medical condition, treatment history, or abnormal test result that the trial doctor believes could affect the results or the person's ability to safely participate (confirm with trial site).
• People who have been diagnosed with another cancer in the past 5 years.
• People with known cancer spread to the brain or central nervous system.
• People with uncontrolled high blood pressure, uncontrolled diabetes, interstitial lung disease, or chronic obstructive pulmonary disease.
• People who have been receiving medication to suppress or modify the immune system for an autoimmune condition within the past 2 years.
• People with a more severe level of heart failure (classified as NYHA class III).
• People who are pregnant or currently breastfeeding.
• People who the trial doctor assesses as unable or unwilling to follow the trial's requirements.

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