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Many people with muscle invasive bladder cancer have their bladder removed as part of their treatment. This surgery can greatly affect a person’s quality of life. For example, it can change how people go to the bathroom and may affect sexual health. This study looks at whether giving pembrolizumab along with radiation therapy can help people avoid bladder removal surgery. Pembrolizumab may help the body's immune system find and attack cancer cells and may slow the growth and spread of the tumor. If you decide to join the study, you will first have exams, tests, or procedures to see if the study is right for you. If you qualify, you will get pembrolizumab once every 3 weeks for one year. The drug is given through an IV, which means a small needle is placed into a vein in your arm. You will also get radiation treatment once a day, Monday through Friday, for about one month. In total, you will have 20 radiation treatments. During the study, you will have exams, tests, and procedures to check your health and safety. Most of these are part of your usual care. Some blood, urine, and tissue samples will be collected only for the research study. You will be in the study for 5 years. You will get treatment during the first year. After treatment ends, you will have study visits every 6 months until 2 years after treatment. After that, you will have study visits once a year for the rest of the study. At these visits, the study doctor will check to see how you are feeling and if the cancer has come back or has gotten worse. You and your insurance will need to pay for your routine medical care. You will not be paid for being in this study.

Who can Participate

You may be able to join this study if you have muscle invasive bladder cancer and have already received chemotherapy, immunotherapy, targeted drugs, or a combination of these treatments. You must also have had a surgery called transurethral resection of bladder tumor. After these treatments, your tumor must have gotten smaller or is no longer seen. You cannot join this study if you have already received radiation therapy, certain immunotherapy, or targeted drugs for other types of cancers. You also cannot join if you need to take steroids, such as prednisone, to control your immune response. People who are pregnant or breastfeeding also cannot take part in the study. Your doctor or a member of the study team will talk with you about other requirements needed to join. More information about this study is available on ClinicalTrials.gov.

Study ID

More information available at ClinicalTrials.gov: NCT07061964