This clinical trial is focused on studying a type of kidney cancer known as Metastatic Renal Cell Carcinoma (RCC), which is an advanced form of cancer that has spread beyond the kidney. The study is investigating the effectiveness and safety of a combination of medications in patients who have not received prior treatment for this condition. The medications being tested include Cabozantinib, Nivolumab, and Ipilimumab. Cabozantinib is taken as a tablet, while Nivolumab and Ipilimumab are given as infusions, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to compare the combination of Cabozantinib, Nivolumab, and Ipilimumab against the combination of Nivolumab and Ipilimumab alone. Participants will be randomly assigned to receive either the three-drug combination or the two-drug combination. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know which treatment each participant is receiving, to ensure unbiased results. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients.

The study will take place over a period of time, with regular visits to monitor the participants’ health and the effects of the treatment. The main goal is to see how long the participants live without the cancer getting worse, known as Progression-Free Survival (PFS). The study will also look at overall survival, which is the length of time participants live after starting the treatment. Participants will be closely monitored for any side effects or changes in their condition throughout the study.