Phase 2 Bladder Cancer Trial, Recruiting

Written by an AI model from the 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 voluntarily, can give written consent, and are able to follow the study schedule and requirements.
• People who are 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed through tissue testing and imaging with a specific type of bladder cancer (urothelial carcinoma) at certain stages — meaning the cancer is in the bladder but has not spread to nearby lymph nodes or distant parts of the body. If the tumour is a mixed type, urothelial carcinoma must make up at least half of it.
• People whose general health and ability to carry out daily activities is rated as fully active or restricted only in strenuous physical activity (confirmed using a standard medical scoring tool).
• People whose tumour tissue shows a certain level of a protein called HER2 (rated 1+ or higher on a standard laboratory test).
• People who have tumour tissue available from a bladder surgery procedure called TURBT, along with the related pathology report.
• People whose blood test results within 14 days before enrolling show that the blood, liver, and clotting functions are within acceptable ranges, and whose lung function is sufficient to tolerate surgery.
• Women who are not pregnant and, if able to become pregnant, are willing to use highly effective contraception during the study and for at least 120 days after the last dose of study treatment, and who have a negative pregnancy test within 7 days before enrolling.
• Men who have not been surgically sterilised and are willing 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:

• People who have previously received treatments that target certain immune checkpoint proteins (such as PD-1, PD-L1, PD-L2, CTLA-4, LAG-3) or treatments specifically targeting HER2 or Nectin-4.
• People who have received other approved cancer-fighting or immune-modifying treatments (such as interferon or interleukin-2) within the 28 days before enrolling.
• People who have previously had radiotherapy directed at the bladder.
• People who have previously received anti-cancer drug treatment, unless at least 12 months have passed since the last systemic chemotherapy, or at least one week has passed since local bladder chemotherapy or immunotherapy.
• People who have had major surgery or a serious physical injury within 28 days before enrolling (note: the bladder surgery TURBT and placement of a vascular access device are not considered major surgery for this purpose).
• People who have a serious ongoing infection requiring systemic antibiotic, antifungal, or antiviral treatment within 14 days before enrolling.
• People who have received a live vaccine within 28 days before enrolling (standard injected flu vaccines are generally permitted; nasal spray flu vaccines are not).
• People with an active autoimmune disease that requires ongoing systemic treatment and that the study doctor believes could affect how the study treatments work.
• People who need long-term high-dose steroid or other immune-suppressing medications that the study doctor believes could affect the study treatments.
• People with any uncontrolled ongoing health condition that, in the study doctor's judgement, could interfere with treatment — including abnormal blood mineral levels, low blood protein, lung disease, uncontrolled diabetes, high blood pressure, heart disease, or other systemic conditions.
• For one specific study group (Arm A): people who have taken a certain type of diabetes medication called a DPP-4 inhibitor within the past 60 days, people with diabetes who require any blood sugar-lowering medication, or people with unusually low fasting blood sugar levels.
• For another specific study group (Arm D): people with certain gallbladder or bile duct problems, including acute inflammation, blockage, recurring pain episodes, calcified gallstones, impaired gallbladder function, or a gallbladder that cannot be seen on imaging.
• People with untreated or poorly controlled hepatitis B infection (confirm specific viral load thresholds with trial site). People with stable, well-controlled hepatitis B on ongoing antiviral therapy may be assessed for eligibility by the trial site.
• People with active hepatitis C infection. People with negative test results, or positive antibody results but no detectable virus, may be assessed by the trial site.
• People with a history of immune system deficiency, including a positive HIV test, inherited or acquired immune disorders, or prior stem cell or organ transplant.
• People with a known allergy to monoclonal antibodies (a type of laboratory-made protein used in some treatments).
• People with a known allergy to any of the study drugs or their ingredients.
• People who still have side effects from a previous treatment that have not returned to their normal or stable baseline level (unless the study doctor determines these are unlikely to pose a safety risk).
• People with an underlying medical condition, or alcohol or drug use, that could interfere with the study treatment or make it difficult to interpret results, or that could put the person at high risk of complications.
• People who are currently taking part in another clinical trial that involves an active treatment or intervention.

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