This study wants to find out if adding radiation therapy to your tumor, along with your regular immune therapy, can help keep your cancer from growing or even make it shrink, compared to using immune therapy alone in people with metastatic kidney cancer who cannot have surgery.
This is a study for people with kidney cancer that has spread to other parts of the body. This is called metastatic renal cell cancer. The usual treatment is immune therapy drugs or immune therapy combined with a targeted drug called a VEGF inhibitor. Researchers want to find out if adding radiation therapy to your kidney tumor, along with the usual treatment, helps you live longer. Radiation therapy uses strong energy beams to kill cancer cells and shrink tumors. The type of radiation used in this study is called stereotactic body radiation therapy (SBRT). SBRT uses special equipment to help place you correctly and give radiation directly to your tumors. This type of radiation may kill cancer cells with fewer treatment sessions, over shorter time, and may cause less harm to healthy tissue. If you want to join this study, you will be randomly placed in one of two groups, like flipping a coin. One group will get the usual immune therapy treatment. This is either 2 immune therapy drugs or immune therapy plus a targeted therapy drug called VEGF inhibitor. You will stay on this treatment until it is no longer working to control your cancer. The other group will get the same immune therapy but will also get radiation therapy to your kidney tumor. If you are in this group, you will get radiation on 3 different days during the first 3 weeks of starting immune therapy. During the study, you will give blood and urine samples. You will have brain imaging, a chest CT, and a bone scan, along with your routine medical tests. If your tumor gets smaller after 2 years of treatment, your doctor will talk with you about stopping treatment. After treatment stops, your doctor and study team will continue to check you for side effects. They will check you every 6 months for 5 years after treatment, and then once a year for 3 more years. You will have X visits during the 8-year study. You and your insurance will pay for routine medical care costs like doctor visits, tests, and treatments. You will not be paid for being in the study.
You may be able to join this study if you are 18 years old and have kidney cancer that has spread to other places in your body. You can join if you cannot have surgery to remove your tumor or if you choose not to have surgery. More details about who can and cannot join are on ClinicalTrials.gov. Your study doctor or study team member will review these requirements with you.
Protocol Number: 24-2480
More information available at ClinicalTrials.gov: NCT05327686
Principal Investigator