A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy in Subjects with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
This important study is for people with advanced kidney cancer that has spread and hasn't had treatment yet. Doctors want to see if a new combination of two powerful medicines, Nivolumab and Ipilimumab, works better than a common treatment called Sunitinib. They will be comparing how long people live and how long it takes for the cancer to grow or spread. The study will also look at how these treatments affect your overall health, any side effects you might have, and your quality of life. This is a Phase 3 study, meaning it's a large trial to confirm if these new treatments are safe and effective, and potentially better than current options.
At a glance
What is this study about?
This research is specifically designed for people who have advanced kidney cancer, meaning it has spread to other parts of the body, and they haven't received any treatment for it yet. The main goal is to find out if a new treatment approach, using two medicines together (Nivolumab and Ipilimumab), is more effective than a standard treatment called Sunitinib. Think of it like comparing two different routes to the same destination – doctors want to see which route gets you there more safely and quickly, and helps you stay there longer.
The study will carefully track two key things: how long people live after starting treatment, and how long it takes for the cancer to grow or spread. These are called the 'primary endpoints', and they are the most important measures of how well the treatments are working. But it's not just about these numbers. The researchers will also be looking at many other important aspects, such as how much the tumours shrink, how long any improvements last, and how you feel generally. This holistic view helps doctors understand the full impact of the treatment on your life.
They will also be keeping a close eye on any side effects you might experience, how the treatments affect your day-to-day life and well-being (your quality of life), and even the cost of care. This detailed information will help medical experts decide if the new combination treatment is a better option for people with advanced kidney cancer in the future.
Key takeaways
- This study compares two different treatment approaches for advanced, untreated kidney cancer.
- It aims to see if two new medicines together are better than a standard treatment.
- The main goals are to improve how long people live and stop the cancer from growing.
- You would receive either a combination of Nivolumab and Ipilimumab, or Sunitinib.
- Participation involves regular hospital visits for assessments and medication.
- You can withdraw from the study at any time.
Who may be eligible?
This study is for adults aged 18 years and older. Both men and women can take part. To be considered, you must have advanced kidney cancer that has spread to other parts of your body, and you must not have received any previous treatment for this advanced stage of cancer.
There might be other specific health requirements or conditions that would mean you can or cannot join. For example, your overall health, how well your organs are working, and any other medical conditions you have will be important factors. These details are checked very carefully by the study team to make sure it's safe for you to participate and that the study results are clear.
It's important to understand that not everyone with advanced kidney cancer will be able to join this study. If you are interested, your doctor will review all your medical information to see if you meet all the necessary criteria.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am 18 years old or older.
- I have advanced kidney cancer that has spread.
- I have not had any previous treatment for my advanced kidney cancer.
- I understand I will be randomly assigned to a treatment group.
- I am willing to have regular medical tests and appointments.
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to one of two treatment groups – like flipping a coin, but done by a computer to ensure fairness. One group will receive the combination of Nivolumab and Ipilimumab, and the other group will receive Sunitinib. You won't get to choose which treatment you receive.
You will have regular visits to the hospital or clinic. During these visits, you'll have various assessments, which might include blood tests, urine tests, physical exams, and scans (like CT or MRI scans) to monitor your cancer and your overall health. You will receive your assigned medication, which might be given as an infusion (through a drip) or as capsules to take by mouth, depending on your treatment group. The study team will closely monitor you for any side effects and how you are feeling.
The total duration of your participation will vary. You will continue treatment as long as it is working for you and you are tolerating it well. Even after you stop the main treatment, there will likely be follow-up visits or phone calls to check on your long-term health and the progress of your cancer.
Potential risks and benefits
Locations (13)
- —UnverifiedGermany
- —UnverifiedIreland
- —UnverifiedHungary
- —UnverifiedAustria
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedFinland
- —UnverifiedCzechia
- —UnverifiedDenmark
- —UnverifiedSweden
- —UnverifiedBelgium
- —UnverifiedItaly
Common questions
What is advanced renal cell carcinoma?
It's a type of kidney cancer that has spread from the kidney to other parts of the body.
What does 'untreated' mean in this study?
It means you haven't received any treatment for your kidney cancer once it has spread.
What are Nivolumab, Ipilimumab, and Sunitinib?
These are different medicines used to treat cancer. Nivolumab and Ipilimumab are given together, while Sunitinib is given on its own in this study.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, which means both you and your doctor will know which treatment you are receiving.
What does a 'Phase 3' study mean?
It's a large-scale study that compares a new treatment with an existing one to see if it's better and safer before it can be widely used.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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