A trial comparing nivolumab and ipilimumab with standard treatment for head and neck cancer (CA209651)

Cancer type:

Head and neck cancers
Laryngeal cancer
Mouth (oral) cancer
Pharyngeal cancer

Status:

Open

Phase:

Phase 3

This trial is for people with head and neck cancer that has either come back (recurrent cancer) or spread elsewhere (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:

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 standard treatment Open a glossary item. You might hear this treatment called the EXTREME regimen. 

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 
  • 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 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. 

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 biomarker Open a glossary item called PD-L1
  • 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:

Cancer related

  • You have had treatment that reached your whole body (systemic treatment Open a glossary item) 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 Open a glossary item. 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 Open a glossary item) or basal or squamous cell skin cancer that have been successfully treated

Medical conditions

  • You have an autoimmune disease Open a glossary item 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 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 vaccines Open a glossary item such as the yellow fever vaccine
  • You have a serious infection such as shingles Open a glossary item or chickenpox
  • You are known to be sensitive to platinum chemotherapy  Open a glossary itemsuch 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 

Other

  • You are pregnant or breastfeeding

Trial design

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.

study diagram

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.

Standard treatment
You have a combination of 3 drugs: 

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.

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 and at set times during the trial. 

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

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

Hospital visits

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

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

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. 

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 combined with ipilimumab are: 

We have more information about nivolumab and ipilimumab.

And information about:

Location

Birmingham
London
Manchester
Newcastle upon Tyne
Sheffield
Southampton
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

Professor. Kevin Harrington

Supported by

Bristol-Myers Squibb

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14715

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

A picture of Wendy

"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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