"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial comparing nivolumab and ipilimumab with standard treatment for head and neck cancer (CA209651)
More about this trial
Head and neck cancers can sometimes come back or spread to another part of the body. This is recurrent or metastatic head and neck cancer.
When this happens, you usually have treatment with chemotherapy using a combination of:
This is the
In this trial you have 1 of the following:
- nivolumab and ipilimumab
- standard treatment
The main aims of this trial are to:
- find out how well nivolumab and ipilimumab work as a treatment
- learn about the side effects
- find out what happens to nivolumab and ipilimumab in the body
- look for proteins (biomarkers) to see why treatments work better for some people than others
- find out more about people’s
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.
You may be able to join this trial if all of the following apply:
- You have squamous cell carcinoma of the head and neck that has come back or spread to another part of your body
- You are not able to have any treatment such as radiotherapy or surgery to cure your cancer
- You have a suitable sample of cancer available (or be willing to have a sample taken) to be tested for a
- Your cancer has been tested for the human papilloma virus (HPV) if you have oropharyngeal cancer. If it hasn’t been tested, then you must have a suitable sample of cancer available (or be willing to have a sample taken)
- You have at least 1 area of cancer that can be seen on a scan and measures at least 10 mm
- You have satisfactory blood tests results
- You are at least 18 years old
- You are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
Women must be willing to use reliable contraception during treatment and for 23 weeks (about 3 months) after the last dose of nivolumab and ipilimumab if there is any possibility of becoming pregnant. Men must be willing to use reliable contraception during treatment and for 31 weeks (about 8 months) after the final dose of nivolumab and ipilimumab, if there is any possibility their partner could become pregnant.
If you have standard treatment, the trial team will advise you how long you should use reliable contraception for.
You cannot join this trial if any of these apply:
- You have had treatment that reached your whole body (
systemic treatment) after your cancer came back or spread to another part of your body
- Your cancer has spread to your brain, the tissues surrounding your brain or your
spinal cord. You might still be able to take part if you have had treatment, you no longer have side effects and you haven’t taken, or have been on a stable dose, of steroids for the past 2 weeks
- You have had nivolumab, ipilimumab, cetuximab or any other similar drugs
- You have had radiotherapy to relieve symptoms (palliative radiotherapy) in the past month (2 months if it was radiotherapy to your head or neck)
- You have, or have had, side effects from previous anti cancer treatment (apart from hair loss and tiredness) in the last 2 weeks
- You have, or have had another cancer in the past 2 years apart from certain early cancers (
carcinoma in situ) or basal or squamous cell skin cancer that have been successfully treated
- You have an
autoimmune diseaseunless it is 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
- You have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 2 weeks (unless this was a cream, an inhaler or a very small dose)
- You have lung problems such as interstitial lung disease that is causing you symptoms
- You have hearing problems
- You are having live
vaccinessuch as the yellow fever vaccine
- You have a serious infection such as
- You are known to be sensitive to
platinum chemotherapysuch as cisplatin, or to the drugs nivolumab or ipilimumab
- You have HIV
- You have hepatitis B or hepatitis C
- You have any other medical condition or mental health problem that the trial team thinks could affect you taking part in this trial
- You are pregnant or breastfeeding
This is an international phase 3 trial. The researchers need about 490 people worldwide and around 30 people from the UK to take part.
This trial is randomised. The people taking part are put into 1 of the following treatment groups by computer:
- nivolumab and ipilimumab
- standard treatment
Neither you nor your doctor are able to decide which group you are in. But you will know which treatment you are having.
Nivolumab and ipilimumab
You have both drugs as a drip into a vein. This takes over 30 minutes each time.
You have nivolumab every 2 weeks and ipilimumab every 6 weeks.
You continue to have nivolumab and ipilimumab for as long as it is helping you and the side effects aren’t too bad. This can be for up to 2 years.
You have a combination of 3 drugs:
- 5-fluouracil (5FU)
- cisplatin or carboplatin (your doctor will explain which drug is best for you)
You have all 3 drugs through a drip into a vein. You have cetuximab once a week and 5FU with cisplatin or carboplatin every 3 weeks. This continues for 18 weeks (about 5 months). Then you have cetuximab alone.
You continue to have treatment for as long as it is helping you and the side effects aren’t too bad.
Quality of life
Everybody taking part in this trial completes a quality of life questionnaire before starting treatment and:
- every 6 weeks during treatment
- 1 month after you finish treatment
- then every 3 months
It asks about how you have been feeling and what side affects you have had.
You have some extra blood tests as part of this trial. Researchers want to:
- look for certain proteins called biomarkers to see why treatments work better for some people than others
- find the amount of nivolumab and ipilimumab in your body
You have the extra blood tests before starting treatment and at set times during the trial.
You might need to give a tissue sample (
If you have oropharyngeal cancer they will also check if there is a virus on your cancer (the human papilloma virus). If you already had this test done in the past, the trial team will check the result before you start treatment.
Doctors can use a tissue sample of your cancer taken less than 6 months ago. If there isn’t a suitable sample available, you need to have a biopsy.
You might also need to have a new tissue sample taken:
- 7 weeks after the start of treatment
- if your cancer gets worse
You do not have to agree to have a biopsy after 7 weeks if you don’t want to. You can still take part in this trial.
Saliva (spit) sample
The research team might ask you to give a saliva sample before the start of treatment and after 7 weeks.
They want to look at the types of
You see a doctor and have some tests before taking part. These tests include:
During treatment you see the doctor for blood tests and a physical examination every 2 weeks if you have nivolumab and ipilimumab and every 3 weeks if you are in the standard treatment group.
You have a CT scan or MRI scan every 6 weeks while you are having treatment. This continues for a year. After this you have a CT scan or MRI scan every 12 weeks.
Your treatment continues for as long as your cancer stays the same and the side effects aren’t too bad.
When you finish treatment you see the doctor after 1 and 3 months. You have blood tests and a physical examination.
You then see or speak with the trial team every 3 months.
The trial team monitor you during the time you have treatment and you have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start the trial.
The most common side effects of nivolumab combined with ipilimumab are:
- liver problems such as high levels of liver enzymes
- tiredness (fatigue)
- skin rashes and itching
- feeling sick
And information about:
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.
Professor. Kevin Harrington