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 )

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

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 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 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 , squamous cell skin cancer , early bladder cancer or carcinoma in situ (CIS ) 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 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
take a corticosteroid 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
have an active hepatitis B or hepatis C infection
have HIV
are sensitive to drugs called monoclonal antibodies
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 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

Diagram 1

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.

Diagram 2

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
genes

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 )
heart scan (ECHO )
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: