A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

This study is for adults aged 18 and over who have been diagnosed with advanced or metastatic renal cell carcinoma, a specific type of kidney cancer. Your diagnosis needs to be confirmed by a lab test and should be the clear-cell type, though it can also have some other features. You must not have received any previous treatment for your advanced kidney cancer, with one exception: if you had a treatment shortly after your initial diagnosis (adjuvant or neoadjuvant therapy) and your cancer came back at least six months later, you might still be eligible, as long as that previous treatment didn't target certain growth pathways.

There are also some reasons why you might not be able to join. For example, if your cancer has spread to your brain or spine and is causing active problems, you wouldn't be able to participate. Also, if you have certain autoimmune diseases (where your body's immune system attacks itself) or if you're taking high doses of steroids or other medicines that suppress your immune system, you might not be suitable. It’s also important that you haven't received a live vaccine within a month of starting the study.

Your doctor will look at all your medical information carefully to see if this study is right for you. They will have a full list of all the criteria.

If you decide to take part in this study, you will have regular clinic visits where the study team will monitor your health and how you are responding to the treatment. This will involve physical examinations, blood tests, and scans (like CT or MRI) to check on your cancer. You will receive one of the study medications, either the combination of Nivolumab and Cabozantinib, or Sunitinib, typically as tablets or injections, depending on the specific drug.

The total duration of your participation will vary depending on how you respond to the treatment and your health. You will continue with the treatment for as long as it is working and you are tolerating it well. Even after stopping the study medicine, you will have follow-up visits to monitor your health and the long-term effects. The study team will provide you with a detailed schedule of visits and procedures.