What is the RAMPART study?
RAMPART is a randomised controlled trial aimed at kidney cancer patients, whose cancer has been removed by surgery and has not spread to other parts of the body.
The current standard treatment after surgery is ‘active monitoring’. This means no further treatment, but having regular checks so that if the cancer does come back, further treatment options can be considered as early as possible.
We are aiming to find out whether taking one drug (durvalumab) or a combination of two drugs (durvalumab and tremelimumab) for one year following surgery can prevent or delay kidney cancer from coming back compared to the current standard of care (active monitoring after surgery).
Durvalumab is a type of treatment called an immunotherapy, sometimes referred to as an ‘anti-PDL1 drug’ or ‘immune checkpoint inhibitor’. It works by helping your own immune system to attack the cancer.
Durvalumab is currently being tested by itself or in combination with other treatments in many types of cancer. Early studies have shown that durvalumab works well and has side effects that can usually be well controlled.
A similar drug, nivolumab, has been shown to be effective in treating a number of different types of cancer (lung cancer, a type of skin cancer called melanoma and kidney cancer that has spread outside the kidneys).
For these reasons, we think durvalumab is a worthwhile drug to test for kidney cancer patients to see if it will prevent or delay their cancer returning.
Tremelimumab is another immunotherapy treatment for cancer. It may sometimes be called an ‘anti-CTLA4 drug’ or ‘immune checkpoint inhibitor’. It also works by helping your immune system to attack the cancer.
It has been shown to be effective in treating a number of different types of cancer, particularly when used in combination with other cancer treatments.
A similar drug called ipilimumab has been shown to be effective in combination with nivolumab (the drug that is similar to durvalumab) for treating patients with melanoma (a type of skin cancer) that has spread to their organs. The combination is also being tested in kidney cancer that has spread outside the kidney (advanced kidney cancer).
Who can take part?
Individuals will only be able to take part in RAMPART if the hospital where they are being treated is participating in the trial. The study is currently open to recruitment at hospitals throughout the UK and will soon be opening in Australia, France and Spain. Please refer to the Site Map for more details of recruiting sites.
Not everyone who has undergone surgery for their kidney cancer will be able to participate in the study. Some tests will have to be conducted first to see whether they are suitable to take part.
Patients will need to have a CT scan to see if any cancer is still present in their body after surgery. If cancer is present they won’t be able to enter the study, but there are other treatment options available that their doctor will discuss with them.
We also ask that patients provide blood and urine samples for testing, as well as having an electrocardiogram (ECG). An ECG is a simple, painless test that records the heart's electrical activity. These tests are important to make sure that it will be safe to take the study drugs.
If you are an individual who is interested in taking part in RAMPART, please talk to your doctor, who will be able to consider whether you are suitable for the trial.
What treatment will RAMPART patients receive?
If tests show that a patient is fit to take part and they agree to join the RAMPART study, they will be randomly assigned to one of 3 different groups. These are known as Groups A, B and C and are shown in the diagram below. Everyone who takes part will be in one of these groups.
Because we do not know if the new treatments will be better than the current standard of care (no treatment), it is important that the patients in each group are as similar as possible at the start of the study.
As described in the About Clinical Trials page, a process called randomisation is used to allocate people to each group. We use a computer program to do this. Doctors will not have any say in which group their patients are allocated.
For every 7 patients entered into the study, 3 will be allocated to Group A, 2 to Group B and 2 to Group C.