A trial looking at nivolumab before and after surgery for kidney cancer that has spread (ADAPTeR)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a drug called nivolumab for a type of kidney cancer called renal cell cancer. The trial is for people whose kidney cancer has grown outside the kidney or has spread to another part of their body and who haven’t had any treatment yet.
More about this trial
Doctors usually treat renal cell kidney cancer that has spread with types of drugs called biological therapies to stop or slow cancer growth. Your doctor may also recommend that you have surgery to remove your kidney (this is called a nephrectomy). But doctors are looking for ways to improve treatment for this group of people.
In this trial, they are looking at a drug called nivolumab. It is a type of biological therapy called a 
. It triggers the to attack and kill cancer cells
The aims of this trial are to
- Find out if having nivolumab both before and after planned surgery helps people with renal cell kidney cancer that has spread
- Learn more about the side effects
Who can enter
You may be able to join this trial if all of the following apply. You
- Have clear cell renal cell cancer that has grown outside the kidney or has spread to another part of your body
- Have at least one area of cancer spread outside your kidney that can be measured on a scan
- Are due to have surgery to remove your kidney
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are at least 18 years old
You cannot join this trial if any of these apply.
- Your cancer has spread to your brain and is causing symptoms. You may be able to take part if you have had treatment for this and the cancer isn’t causing any symptoms, it has not got any worse for at least 6 months and you haven’t taken
steroids in the last month - Your kidney needs to be removed because of the symptoms the cancer is causing or you need to have an emergency operation to remove your kidney (your doctor can tell you more about this)
- You have had treatment for kidney cancer that reached your whole body (
systemic treatment ) (your doctor can tell you more about this) - You are taking
steroids for any reason - You have had a bad reaction to a monoclonal antibody in the past
- You have an
autoimmune disease that needs treatment (your doctor can tell you more about this) - You have an infection that needs treatment
- You have had a vaccination such as the flu vaccine in the last month
- You have had any other cancer in the last 5 years apart from non melanoma skin cancer or a very early stage of cancer called
carcinoma in situ that has been successfully treated - You are hepatitis B, hepatitis C or HIV positive
- You have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial
- You are pregnant or breastfeeding
Trial design
This is a phase 2 trial. The trial team need 19 people to take part. Everyone will have nivolumab and surgery.
To begin with, you have nivolumab for 2 months. You then have surgery to remove your kidney. Once you have recovered from surgery, you have further treatment with nivolumab. This time you have it for as long as it is helping you and the side effects aren’t too bad.
You have nivolumab through a drip into a vein. During treatment you have it every 2 weeks. It takes about an hour each time.
If you agree to take part in this study, the researchers will ask for a number of samples of your cancer () when you join the trial, when you have surgery and when you finish treatment. The researchers will use these samples to look for substances called . This may help them understand more about how nivolumab works and how it affects your cancer.
Hospital visits
You see the doctor and have some tests before taking part in the trial. These include
- Physical examination
- Blood tests and urine tests
- CT scan
- A test to see how well your lungs are working
- A kidney biopsy
During treatment, you go to hospital every 2 weeks.
You have a CT scan before and after your operation and then every 2 months for a year. After that you have a scan every 3 months for as long as you are having nivolumab. When you stop having treatment, the trial team will follow you up to see how you are getting on. This may be at routine hospital appointment or they may check your medical records to see how you are.
Side effects
The most common side effects of nivolumab include
- Tiredness (fatigue)
- Skin reactions such as rash, itching, redness or dry skin
- Diarrhoea
- Feeling sick
- Tummy (abdominal) pain
- Loss of appetite
- A drop in the number of red blood cells causing tiredness and breathlessness
- Joint pain or stiffness
- High temperature (fever)
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Dr James Larkin
Supported by
Bristol-Myers Squibb
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
