A trial looking at nivolumab and ipilimumab for people with head and neck cancer (CA209714)

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

Cancer type:

Head and neck cancers

Laryngeal cancer

Mouth and oropharyngeal cancer

Pharyngeal cancer

Status:

Closed

Phase:

Phase 2

This trial is for people with head and neck cancer that has either come back (recurrent cancer) or spread to another part of the body (metastatic cancer).

It is for people who haven’t had treatment for their recurrent or metastatic squamous cell carcinoma Open a glossary item (SCC) of the:

mouth and oropharynx
larynx

More about this trial

Head and neck cancers can sometimes come back after treatment 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 or a targeted cancer drug (biological therapy).

Nivolumab (Opdivo) and ipilimumab (Yervoy) are 2 types of targeted cancer drugs. They work in slightly different ways but both help the body’s immune system to kill cancer cells.

In this trial you have 1 of the following:

nivolumab and ipilimumab
nivolumab and a dummy drug (placebo )

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
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 or your doctor can’t find out where your cancer has started (cancer of unknown primary) but it has spread to the head and neck area and it has tested positive for the human papilloma virus (HPV)
You are not able to have any treatment to cure your cancer such as surgery or radiotherapy
You have a suitable sample of cancer available (or be willing to have a sample taken) to be tested for a biomarker called PD-L1
Your cancer has been tested for 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 well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are at least 18 years old

Women must be willing to use reliable contraception during treatment and for 5 months afterwards if there is any possibility of becoming pregnant. Men must be willing to use reliable contraception during treatment and for 7 months afterwards, if there is any possibility their partner could become pregnant.

You cannot join this trial if any of these apply:

Cancer related

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 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 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

Medical conditions

You have an autoimmune disease unless 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 either a cream or an inhaler)
You have lung problems such as interstitial lung disease that is causing you symptoms
You are known to be sensitive to platinum chemotherapy, 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

Other

You are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. The researchers need about 315 people worldwide and around 15 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
nivolumab and a dummy drug (placebo)

Neither you nor your doctor are able to decide which group you are in. And neither you nor your doctor will know which group you are in. This is a double blind trial Open a glossary item .

You are 2 times more likely to have nivolumab and ipilimumab than nivolumab and dummy drug.

study diagram

Everyone has nivolumab as a drip into a vein every 2 weeks. It takes about 30 minutes each time.

You also have ipilimumab or the dummy drug as a drip into a vein. You have it every 6 weeks. It takes around 30 minutes each time.

On the days that you have both drugs, you have nivolumab first and then ipilimumab or the dummy drug.

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.

Blood tests
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, at set times during the trial and then after 1 and 3 months of finishing treatment.

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 bacteria Open a glossary item in your mouth to find out why treatments work better for some people than others.

Tissue sample
You might need to give a tissue sample (biopsy ) of your cancer before you start treatment. This is to look for certain proteins and blood cells .

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 also need to have a new tissue sample taken if your cancer gets worse.

Hospital visits

You see a doctor and have some tests before taking part. These tests include:

physical examination
heart trace (ECG )
blood tests
urine test (if you are a woman and able to become pregnant)
a CT scan or MRI scan

After you start treatment you see the doctor for blood tests and a physical examination every 2 weeks.

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. This continues for 5 years.

Side effects

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 are: