The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Metastatic Renal Cell Carcinoma for a research study. The purpose of this study is to compare Standard Systemic Therapy (SST) alone to SST plus surgery to remove all or part of the kidney with tumor. All patients receive SST to shrink the tumor and stimulate the immune system. Your doctor will determine if you are benefiting from SST. Patient who are benefiting from this treatment will be selected by chance to have surgery and then continue SST or continue SST without surgery. It is possible but not certain that surgery will reduce the amount of cancer in the body and allow immune therapy to work better. This study will help the study doctors find out which approach is better, the same, or worse. To decide if it is better, the study doctors will be looking to see if the study which approach increases the lifespan of patients. All of the drugs that are used as part of treatment on this study are commercially available, FDA approved, and considered standard treatment for your kind of kidney cancer.
The study involves receiving the Standard Systemic Therapy and/or surgery, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging of your tumor, and talking to the study doctor. If you decide to take part in this study, you will get either only standard drug combination therapy or you will get the standard drug combination therapy and surgery to remove part or all of your kidney. You will get treatment until your disease gets worse.
After you finish your study treatment, your doctor will continue to follow your condition for up to 7 years. Your doctor will watch you for side effects and to see how the cancer affects you. You will have clinic visits every 12 weeks during your first year of treatment, followed by every 6 months during your second and third year of treatment, unless the kidney cancer becomes worse. After it worsens, you will have clinic visits every 6 months until three years from when you started the study, and then once a year until seven years after you started the study.
You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your kidney cancer.
Additional information can be found here: https://clinicaltrials.gov/study/NCT04510597
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