NCT03361865

Who might be able to join this trial:

• You have been diagnosed with advanced, inoperable, or spread (metastatic) bladder cancer or cancer of the renal pelvis, ureter, or urethra, confirmed by a lab test on a tissue or cell sample.
• Your cancer can be measured on scans using standard guidelines (called RECIST v1.1).
• You have been assessed as not suitable to receive a chemotherapy drug called cisplatin, based on specific trial criteria (confirm with trial site).
• You are able to provide a tissue sample — either from a stored biopsy or a new biopsy — from a tumor that has not previously been treated with radiation, for a specific protein test (PD-L1).
• You have not previously had chemotherapy treatment for your advanced, inoperable, or metastatic urothelial cancer.
• Your general health and ability to carry out daily activities falls within an acceptable range on a standard scale (called ECOG 0, 1, or 2), assessed within 14 days before joining the trial.
• Your organs (such as kidneys, liver, and bone marrow) are functioning well enough to meet the trial's specific requirements (confirm with trial site).

Who may not be able to join:

• Your cancer could still be treated with local treatments aimed at curing it (such as surgery or radiation).
• You have another cancer that is currently growing or has needed active treatment within the last 3 years.
• You have active cancer that has spread to the brain or the lining around the brain, unless previously treated brain spread has been stable for at least 4 weeks, you are clinically stable, and you have not needed steroid medication for at least 14 days before starting the trial.
• You have an autoimmune disease (where your immune system attacks your own body) that has needed medication or treatment in the past 2 years.
• You have a known history of HIV infection.
• You have a known history of active hepatitis B or active hepatitis C (specific blood tests will be needed to confirm this).
• You have a history of a stomach or bowel condition that might affect how your body absorbs a tablet or capsule form of medication.
• You have an abnormal heart tracing (ECG) that the trial doctor considers to be medically significant.
• You are taking certain medications or have had certain previous treatments that are not allowed under the trial's rules (confirm with trial site).

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