Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

To join this study, you would need to have kidney cancer (renal cell carcinoma) that has spread or is advanced, and you haven't received any treatment for it before. Your medical team would also need to confirm that your cancer cells have a specific type called 'clear-cell' and that your cancer falls into a 'middle' or 'higher' risk group based on certain health factors.

Doctors will also check that you are generally well enough to take part, often measured by a score called the Karnofsky Performance Status, where you'd need to be able to do most normal activities. You also need to have good function of your organs, like your heart, liver, and kidneys, and your blood counts should be healthy. The cancer itself needs to be measurable, meaning doctors can track its size.

There are also reasons why you might not be able to join. For example, if you've already had other treatments for your advanced kidney cancer, or if you have certain other serious health issues like uncontrolled high blood pressure, some heart problems, or specific issues with your digestive system. If you have brain tumours that aren't stable after treatment, or if you're taking common blood-thinning medications, you might also not be able to participate. They also generally can't include people who've had certain types of radiation therapy recently or recent live vaccinations.

If you decide to take part in this study, you would be assigned by chance to one of two treatment groups. One group will receive three medicines: cabozantinib, nivolumab, and ipilimumab. The other group will receive nivolumab and ipilimumab, plus a dummy pill (placebo) that looks like cabozantinib but contains no medicine. You, your family, and your doctors won't know which group you're in.

Throughout the study, you'll have regular visits to the hospital for check-ups, blood tests, and scans (like CT or MRI) to see how your cancer is responding and to monitor for any side effects. The medicines will be given in different ways – some might be pills you take by mouth, and others might be given through an IV drip. The duration of the treatment and follow-up will vary, but studies like this often involve treatment cycles over many months, followed by regular check-ins even after treatment stops, to track your long-term health and survival. The total duration of your participation could be several years.