SBRT With Combination Ipilimumab/Nivolumab for Metastatic Kidney Cancer

To join this study, you would typically need to have kidney cancer that has spread, and this must be confirmed by imaging scans like CT or MRI within 10 weeks before starting. Your cancer team will assess your cancer's risk level, and you'll need to be considered intermediate or poor risk to be eligible. Importantly, your main kidney tumour must be suitable for SBRT (focused radiation treatment), and you shouldn't be a candidate for surgery to remove the kidney tumour. You must also be generally well enough to receive the immunotherapy drugs normally.

There are also some reasons why you might not be able to join. For instance, your main kidney tumour can't be too large (under 20 cm). If you've already had other treatments for advanced kidney cancer, you might not be able to participate. Conditions that might make SBRT or the immunotherapy drugs unsafe, such as certain autoimmune disorders or previous radiation to your abdomen, would also prevent you from joining. You'll need to be able to lie flat for at least 30 minutes, and typically, pregnant or breastfeeding women cannot participate.

If you decide to take part in this study, you would be randomly assigned to one of two groups, like flipping a coin. You wouldn't choose which group you're in.

One group (the standard arm) would receive a combination of two immunotherapy drugs, ipilimumab and nivolumab. You'd get these drugs through a drip every three weeks for four cycles. After that, you'd continue with nivolumab alone, typically every two or four weeks, until your cancer gets worse, the side effects become too much, or you and your doctor decide to stop.

The other group (the experimental arm) would first receive one cycle of the ipilimumab and nivolumab drugs. Then, you'd have a special type of radiation called SBRT to your kidney tumour. This radiation is given over about a week and a half. Following the SBRT, you'd then continue with the remaining three cycles of ipilimumab and nivolumab, and just like the other group, you'd move to maintenance nivolumab until your cancer progresses or treatment needs to stop. Throughout your treatment, your medical team will closely monitor you with regular check-ups, blood tests, and scans.