Phase 3 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:

General criteria for all participants:

• People who are willing and able to give their informed consent to take part.
• Men and women aged 18 years or older.
• People who are able to provide tumour tissue samples — either a cell block or at least 15 slides from a previous biopsy.
• People whose tumour tissue has been sent for detailed molecular testing through a commercial service (such as Tempus, CARIS, or Foundation One), including a specific test called PD-L1.
• People whose tumour tests positive for a protein called EphrinB2, as assessed by the USC Norris Core Lab.
• People with a general health and activity level rated at 0 or 1 on a standard medical scale, meaning they are fully active or have only minor limitations on physical activity (confirm with trial site).
• Women of childbearing potential who agree to use contraception, as decided with their treating doctor.
• Women of childbearing potential whose pregnancy blood test during screening comes back negative, OR who have had their uterus and/or both ovaries surgically removed, OR who have medically confirmed ovarian failure, OR who have had no menstrual periods for at least 12 consecutive months (postmenopausal), OR whose hormone (FSH) levels are in the postmenopausal range on a laboratory test.
• Women who are not currently breastfeeding.
• Men who are sexually active with women of childbearing potential and agree to use two forms of contraception with a very low failure rate, continuing for 120 days after the last dose of treatment.
• People whose blood test results, taken within 14 days before joining the trial, show that the kidneys, blood counts, and liver are functioning at or above the required levels (confirm specific values with trial site).

Additional criteria for Module A (muscle-invasive bladder cancer before surgery):

• People diagnosed with urothelial carcinoma (a type of bladder cancer), including certain variant forms — but not pure small cell type.
• People with a specific stage of bladder cancer (cT2 to cT4a, N0M0) confirmed by procedure or imaging (confirm with trial site).
• People who have not received any systemic cancer treatment in the past 12 months.
• People whose insurance has approved the drug pembrolizumab before being randomly assigned to a treatment group, if they are unable to receive cisplatin or choose not to.

Additional criteria for Module B (advanced or metastatic bladder cancer):

• People diagnosed with urothelial carcinoma (a type of bladder cancer), including certain variant forms — but not pure small cell type.
• People whose tumour testing shows the Nectin4 gene is not amplified (tested during pre-screening).
• People who have not received any systemic cancer treatment in the past 12 months.
• People who have measurable disease as defined by standard imaging criteria (RECIST 1.1) (confirm with trial site).

Who may not be able to join:

• People with brain metastases (cancer that has spread to the brain) that are currently causing symptoms and require steroid medication — though people who have already completed treatment for brain metastases, have stopped steroids for at least 4 weeks, and are neurologically stable may still be considered.
• People with a history of, or currently active, autoimmune conditions (such as Crohn's disease, rheumatoid arthritis, lupus, scleroderma, or Graves' disease) or other conditions that affect the immune system.
• People with a known active infection, including hepatitis B, hepatitis C, HIV, or AIDS-related illness.
• People with uncontrolled adrenal insufficiency (a condition where the adrenal glands do not produce enough hormones).
• People with any known active chronic liver disease.
• People who currently have or are being treated for a second cancer that requires systemic treatment.
• People with a known medical condition that, in the investigator's opinion, would increase the risks of being in the trial or make it harder to assess safety results (confirm with trial site).
• People who have had major surgery within 6 weeks, or minor surgery within 4 weeks, before the first dose of the study drug (placement of a vascular access device at least 7 days before the first dose is permitted).
• People with a history of a severe allergic reaction to any monoclonal antibody medication.

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