A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
This research study is investigating new treatment options for people diagnosed with kidney cancer that has spread or is advanced, and who haven't received medication for it previously. The study will compare two different treatment approaches: one group will receive a combination of two drugs, nivolumab (brand name Opdivo) and cabozantinib (brand name Cabometyx). The other group will be given sunitinib (brand name Sutent), which is a common treatment for this type of cancer. The main goal is to find out if the new drug combination can stop the cancer from growing for longer. Researchers will also look at how long people live, how much the tumors shrink, and any side effects people experience with each treatment. This is a large-scale study, which is considered a final step before new treatments might become widely available.
At a glance
What is this study about?
This clinical trial is designed to investigate better ways to treat advanced kidney cancer. When kidney cancer is advanced, it means it has either grown significantly within the kidney or has spread to other parts of the body. For people in this situation who haven't yet received treatment for their advanced cancer, doctors are always looking for more effective options.
In this study, researchers are comparing a new combination of two drugs, nivolumab and cabozantinib, against a standard treatment called sunitinib. Nivolumab is an immunotherapy, which works by helping your body's immune system fight the cancer. Cabozantinib is a targeted therapy designed to block signals that cancer cells need to grow. Sunitinib is also a targeted therapy that has been used for some time to treat kidney cancer.
The main purpose of the study is to see if the new combination treatment can keep the cancer from growing or spreading for a longer period compared to sunitinib. They also want to understand if people live longer, if their tumors shrink, and what side effects each treatment might cause. By doing this, the study aims to determine if the combination of nivolumab and cabozantinib could become a new, better treatment option for patients with advanced kidney cancer.
Key takeaways
- Tests new combination therapy for advanced kidney cancer.
- Compares nivolumab + cabozantinib against standard sunitinib.
- Aims to improve how long cancer growth is controlled.
- Includes regular monitoring and follow-up.
- For people who haven't received previous treatment for advanced disease.
- Participation includes potential risks and benefits, and is voluntary.
Who may be eligible?
To be part of this study, you generally need to be an adult, 18 years or older. There is no upper age limit, meaning people of all ages who meet other criteria can be considered.
The study is open to both men and women. The most important medical condition for joining is having advanced or metastatic kidney cancer, which means the cancer has spread from the kidney to other parts of the body, and you haven't received any treatment for this advanced stage of the disease yet.
There will also be other health checks and medical requirements that your doctor will discuss with you to make sure the study is a safe and suitable option for your specific situation.
- Are you 18 years old or older?
- Have you been diagnosed with advanced or metastatic kidney cancer?
- Have you *not* had any medication treatment for your advanced kidney cancer yet?
- Are you able to take medicines given through a vein and as tablets?
- Are you available for regular hospital visits and follow-up appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll be assigned to one of the treatment groups – either the combination of nivolumab and cabozantinib, or sunitinib. You won't be able to choose which group you're in, as this is decided randomly, like flipping a coin. You will regularly visit the clinic for your treatments, which will be given as either an infusion through a vein (for nivolumab) or as tablets you take by mouth (for cabozantinib and sunitinib).
During these visits, the study team will conduct various checks, including blood tests, physical exams, and scans, to monitor your health, how the treatment is working, and to check for any side effects. These assessments are important to keep you safe and track your progress. The treatment phase of the study will continue as long as the treatment is helping you and you are not experiencing severe side effects.
Even after you stop receiving the study medication, you will likely have follow-up appointments. These follow-ups are important to continue monitoring your health over a longer period, sometimes for several years. The total time you're involved in the study can vary quite a bit, depending on how you respond to treatment and for how long you are followed.
Potential risks and benefits
Locations (7)
- —Poland
- —Spain
- —Czechia
- —Italy
- —Greece
- —Romania
- —Germany
Common questions
What kind of cancer is this study for?
This study is for people with advanced kidney cancer that has spread to other parts of the body and who haven't had treatment for it yet.
What drugs are being tested?
The study is comparing a combination of nivolumab (Opdivo) and cabozantinib (Cabometyx) against sunitinib (Sutent), a standard treatment.
Will I get to choose which treatment I receive?
No, treatments are chosen randomly, like drawing lots, to ensure the study is fair and scientific.
What is the main goal of the study?
The main goal is to see if the new combination treatment can stop the cancer from growing for a longer time than the standard treatment.
How long will I be in the study?
The time you spend in the study can vary. It includes treatment periods and follow-up appointments, which could last several years.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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