A Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer
This research study is for people with kidney cancer that has spread to other parts of the body and who haven't had treatment for it before. It's testing two different types of drug combinations: Nivolumab and Ipilimumab, or a VEGFR tKi. The main goal is to find out how many patients' tumours shrink or disappear after treatment. Doctors will carefully measure changes in the cancer using scans. We also want to see how long people live, how long they stay well without their cancer getting worse, and how long the treatment itself lasts. Safety is very important too, so we'll be watching out for any side effects. This is a "Phase 2" study, meaning it's exploring if these treatments work well enough to be studied further.
At a glance
What is this study about?
This study is looking into new ways to treat kidney cancer when it has spread from where it started. We're focusing on people who haven't received treatment for this type of advanced kidney cancer before. The study is comparing two different treatment approaches: one involves a combination of two medicines called Nivolumab and Ipilimumab, and the other uses a type of drug called a VEGFR tKi. These medications work in different ways to fight cancer.
The main thing we want to learn from this study is how many patients respond to these treatments. A "response" means that the cancer either shrinks significantly or completely disappears when doctors check it with scans. We’ll also be looking at how long people live, how long they stay well without their cancer getting worse, and how long they can continue taking the treatment. Understanding these things helps us decide if these new treatments are promising enough to offer more people in the future.
This is a "Phase 2" study. This means we're exploring if these treatments are safe and effective enough to potentially help people with kidney cancer. We are carefully monitoring participants to see how the treatments affect their cancer and to track any side effects. This research is crucial for finding better, more effective ways to manage advanced kidney cancer.
Key takeaways
- This study is for advanced kidney cancer that hasn't been treated before.
- It tests two different drug combinations to see how well they shrink cancer.
- The treatments being studied are immunotherapy (Nivolumab + Ipilimumab) or targeted therapy (VEGFR tKi).
- Participation involves regular hospital visits for treatments, scans, and blood tests.
- The goal is to find better ways to treat this type of kidney cancer.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
This study is designed for adults aged 18 years and older who have kidney cancer that has spread to other parts of their body (this is called 'metastatic' cancer).
To be considered for this study, you must not have received any previous treatment for your metastatic kidney cancer. Both men and women are welcome to participate.
There will be other detailed medical checks to make sure the study is a good fit for you and that it's safe for you to take part. For example, doctors will need to check your general health, including your blood tests and organ function.
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.
- Are you 18 years old or older?
- Do you have kidney cancer that has spread?
- Have you NOT received any previous treatment for your metastatic kidney cancer?
- Are you able to attend regular hospital appointments?
- Are you in generally good health, apart from your cancer?
What does participation involve?
If you decide to take part in this study, you will receive one of the study treatments. This could involve receiving medicines through a drip (an IV infusion) or taking tablets, depending on which treatment group you are in. You will need to attend regular appointments at the hospital for treatments, scans (like CT or MRI), and blood tests. These appointments help the study team monitor how you are responding to the treatment and check for any side effects.
The frequency of visits will be set out by the study team, but typically, you might have more frequent visits at the beginning of the treatment, becoming less frequent over time if the treatment is working well. The study aims to look at how long the treatment works and how long you are on it. There will also be follow-up appointments after you finish your treatment to continue monitoring your health. The total duration of your participation, including follow-up, can vary from person to person.
Potential risks and benefits
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Common questions
What is 'metastatic kidney cancer'?
This means the kidney cancer has spread from your kidney to other parts of your body.
What are Nivolumab and Ipilimumab?
These are types of drugs called 'immunotherapies' that help your body's immune system fight cancer.
What is a 'VEGFR tKi'?
This is a targeted drug that blocks specific signals cancer cells need to grow and form new blood vessels.
What does 'Phase 2 study' mean?
It means this study is testing if the treatments are safe and show signs of working well enough to be studied in a larger group of people later on.
Will I know which treatment I'm getting?
The study team will explain the treatment you'll receive if you are eligible and decide to join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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