A trial looking at nivolumab before and after surgery for kidney cancer that has spread (ADAPTeR)

Cancer type:

Kidney cancer
Renal cell carcinoma

Status:

Open

Phase:

Phase 2

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 monoclonal antibody Open a glossary item. It triggers the immune system Open a glossary item 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 Open a glossary item 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 Open a glossary item) (your doctor can tell you more about this)
  • You are taking steroids Open a glossary item for any reason
  • You have had a bad reaction to a monoclonal antibody in the past 
  • You have an autoimmune disease Open a glossary item 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 Open a glossary item 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 (biopsies Open a glossary item) 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 biomarkers Open a glossary item. 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

Location

London
Sutton

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr James Larkin

Supported by

Bristol-Myers Squibb
The Royal Marsden NHS Foundation Trust

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11763

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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