A trial of nivolumab with or without ipilimumab after surgery for kidney cancer (CheckMate 914)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Kidney cancer
Renal cell cancer

Status:

Closed

Phase:

Phase 3

This trial is looking at ipilimumab and nivolumab or nivolumab on its own for kidney cancer.

It is for people having surgery for kidney cancer who have a high risk of the cancer coming back.

More about this trial

To treat kidney cancer you can have surgery to remove the whole kidney or part of it. But some people have a higher risk of the cancer coming back. So researchers are looking at having treatment after surgery. In this trial they are looking at 2 drugs called nivolumab and ipilimumab. These drugs are already used for people whose kidney cancer has spread elsewhere in the body.

Nivolumab and ipilimumab are both types of immunotherapies. They work in different ways to help the immune system to find and kill cancer cells. 

In this trial everyone has surgery and:

  • some people have nivolumab and ipilimumab
  • some people have only nivolumab 
  • some people have a dummy drug or dummy drugs (placebo Open a glossary item)

The main aims of the trial are to find out:

  • how well treatment works to stop or delay the cancer coming back 
  • more about the side effects
  • more about how treatment affects quality of life Open a glossary item

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part
You may be able to join the trial if one of the following applies. You:

  • have stage 2 or stage 3 kidney cancer that hasn’t spread into the lymph nodes Open a glossary item or to other parts of the body 
  • have stage 4 kidney cancer  and there is no sign that it has spread into the lymph nodes Open a glossary item or elsewhere in the body
  • have kidney cancer that is any stage and has spread to a lymph node but not to anywhere else in the body

As well as the above, all of the following must apply. You:

  • have kidney cancer that has been completely removed with an operation 
  • have the most common type of kidney cancer called renal cell cancer
  • can be put into a treatment group between 4 and 12 weeks after having surgery
  • gave a tissue sample in the last 3 months or there is one available from surgery for the trial team to do some tests on 
  • are willing to use reliable contraception for up to 7 months if you are a man and your partner could become pregnant or for at least 5 months after treatment if you are a woman and there is any chance you could become pregnant 
  • are well enough to carry out all your normal activities but might not be able to do heavy physical work (performance status of 0 or 1
  • are at least 18 years old 

Who can’t take part

You cannot join this trial if any of these apply. 

Cancer related 
You:

  • have cancer that has spread to another part of the body
  • have had nivolumab, ipilimumab or any other similar drug in the past
  • have already had treatment for kidney cancer 
  • have had another cancer in the last 3 years. This doesn’t include basal cell skin cancer Open a glossary item, squamous cell skin cancer Open a glossary item, early bladder cancer or carcinoma in situ (CIS Open a glossary item) of the prostate, cervix or breast that were successfully treated. And there have been no signs of these cancers since. 

Medical conditions 
You: 

  • have an autoimmune disease Open a glossary item  unless it is white patches on the skin (vitiligo), type 1 diabetes, hair loss (alopecia), thyroid problems that are controlled by medications or a skin condition called psoriasis that doesn’t need treatment that reaches the whole body
  • have an active or ongoing infection and you need antibiotics as a drip Open a glossary item
  • take a corticosteroid Open a glossary item that is equal to or more than 10mg of prednisolone a day or you had steroids within 14 days of starting trial treatment apart from inhalers, eye drops, cream or steroids to replace hormones in the body
  • have a problem with your adrenal glands Open a glossary item
  • have an active hepatitis B or hepatis C infection
  • have HIV
  • are sensitive to drugs called monoclonal antibodies Open a glossary item
  • have any other medical condition or mental health problem that the trial team think will affect you joining the trial 

Other 
You:

  • have had a live vaccination Open a glossary item within 30 days of starting treatment 
  • take herbal supplements or traditional Chinese medicine within 2 weeks of having treatment in the trial 
  • are allergic to any of the drugs in the trial 
  • are pregnant or breastfeeding

Trial design

This phase 3 trial is taking place worldwide. The researchers hope to find 1,600 people to take part including 80 from the UK.

There are 2 parts to this trial, part A and part B. Your doctor will tell you whether you will join part A or part B. Please note that part A is now closed. Part B is open for people to join. 

This is a randomised trial. In each part a computer puts you into a treatment group. Neither you nor your doctor can decide which treatment you have. Nor will you know which treatment group you are in. 

Part A (closed to recruitment)
In part A there are 2 treatment groups. People have 1 of the following:

  • nivolumab and ipilimumab 
  • 2 dummy drugs

Part B (open to recruitment)
In part B there are 3 treatment groups. You have 1 of the following

  • nivolumab and ipilimumab 
  • 2 dummy drugs
  • nivolumab and a dummy drug

A quarter of those randomised have nivolumab and ipilimumab, a quarter have both dummy drugs and half have nivolumab and a dummy drug.


You have all your treatment as a drip into a vein. Each drug takes about 30 minutes.

Depending on which group you are in you have:

  • nivolumab or the dummy drug once every 2 weeks
  • ipilimumab or the dummy drug once every 6 weeks 

You have treatment for up to 6 months.

Samples for research 
The researchers ask for a sample of tissue from your surgery. They also ask for a sample from when you were first diagnosed. You give some extra blood samples as part of the trial. 

The researchers plan to look for:

  • biomarkers Open a glossary item
  • genes Open a glossary item

This will help them to understand more about kidney cancer and how best to treat it.

Hospital visits

You see the doctor to have some tests before taking part in the trial. These include:

  • physical examination 
  • blood tests
  • urine tests
  • heart trace (ECG Open a glossary item)
  • heart scan (ECHO Open a glossary item)
  • CT scan or MRI scan 

You have treatment at the hospital in the outpatient department.

You have a CT or MRI scan at:

  • 9 months 
  • 1 year
  • every 6 months in the 2nd to 5th year of the trial
  • once a year after that for up to 10 years 

When you stop treatment you see the team for a check up at 1 month and 3 months. After that the team call you every 3 months to see how you are getting on.

Side effects

The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better. 

Nivolumab or ipilimumab can affect the immune system. They may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening.

If you have any of these side effects, you should tell the doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

 

The most common side effects of nivolumab are:

The most common side effects of the combination of nivolumab and ipilimumab are:

We have more information about:

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 Thomas Waddell

Supported by

Bristol-Myers Squibb

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16963

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

Wendy took part in a new trial studying the possible side effect of hearing loss

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"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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