A trial looking at nivolumab or standard treatment for head and neck cancer that has come back or spread to another part of the body (CA209141)

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 (oral) cancer




Phase 3

This trial is comparing a new drug called nivolumab with standard treatment for head and neck cancer that has come back or spread to another part of the body. Nivolumab is pronounced nih-vol-yoo-mab.

If you have a head and neck cancer that is a squamous cell cancer Open a glossary item, you usually have treatment with surgery, radiotherapy or chemotherapy, or a combination of these.

If the cancer comes back or spreads to another part of the body after treatment, it can be more difficult to treat. In this situation you may have treatment with chemotherapy drugs such as docetaxel or methotrexate.

Nivolumab is a type of biological therapy called a monoclonal antibody. These are drugs that seek out cancer cells by looking for particular proteins.

The aims of this trial are to find out whether nivolumab works better than docetaxel or methotrexate in treating cancers of the head and neck that have spread or come back.

Who can enter

You may be able to join this trial if you have squamous cell cancer Open a glossary item of the head and neck such as


  • You have cancer that is locally advanced or has spread (stage 3 or 4 cancer) – your doctor can tell you which stage you have, depending on your type of head and neck cancer
  • Your cancer has come back or has spread to another part of your body within 6 months of having chemotherapy with a platinum drug Open a glossary item
  • You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • You have cancer that can be measured on a scan
  • Your doctor has stored a sample of your cancer that can be tested by the trial team. This sample of tissue must have been taken before you had any treatment that circulates throughout your body, for example chemotherapy.
  • You have satisfactory blood tests
  • You are willing to use reliable contraception during the trial and for at least 6 months afterwards if there is a chance that you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have nasopharyngeal cancer, or salivary gland cancer, or other non squamous cell cancers of the head and neck
  • Have cancer that has spread to your brain or is pressing on your spinal cord (spinal cord compression) and this hasn’t been treated or is causing symptoms. (You can take part if you have had treatment, it is not getting worse and you have not had high doses of steroids in the last 2 weeks.)
  • Have had chemotherapy, biological therapy or treatment in a trial in the last 4 weeks, (there may be some exceptions to this that the trial team can advise you about)
  • Have had radiotherapy in the last 4 weeks (you may be able to take part if  you have had radiotherapy to control the growth of your cancer or relieve symptoms more than 2 weeks ago)
  • Have already had treatment with nivolumab or similar drugs
  • Have an autoimmune disease Open a glossary item
  • Have taken steroids or other drugs that damp down your immune system in the last 2 weeks (steroid cream and inhalers are allowed)
  • Are known to be HIV, hepatitis B or hepatitis C positive
  • Have had any other cancer in the last 3 years, unless it was a very early stage and has been successfully treated (the trial team can advise you about this)
  • Are still having side effects from any anti cancer treatment, apart from hair loss and tiredness (fatigue)
  • Have any other medical condition that the trial doctor thinks could affect your taking part
  • Are allergic to the drugs used in this trial, anything they contain, or to similar drugs

Trial design

This international phase 3 trial is recruiting 225 people, including about 12 people from the UK.

It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • People in one group have nivolumab
  • People in the other group have treatment recommended by the trial doctor

If you have treatment recommended by the trial doctor, you will have either docetaxel or methotrexate. These are 2 standard treatments already used to treat head and neck cancer.

There are twice as many people in the nivolumab group as in the group having standard treatment.

CA209141 trial diagram

You have all of these drugs through a drip into a vein. You have nivolumab every 2 weeks and the treatment takes about an hour each time.

You have docetaxel every week and this takes about an hour. You doctor may recommend that you have a break every 3 weeks. So you have weekly treatment for 2 weeks, then no treatment in the 3rd week.

You have methotrexate every week and this lasts for about an hour.

After your first treatment, you may have extra treatments with the same drug every 1 or 2 weeks. This depends on the drug you are having and how well the treatment is working. The trial team will explain this if it applies to you.

People in either treatment group can carry on having treatment for as long as it is helping and you don't have bad side effects.

If you are having one of the chemotherapy treatments and your cancer starts to grow again you will stop treatment. Your doctor may discuss other treatment options with you.

If you are having nivolumab and your cancer starts to grow, your doctor will decide whether you continue treatment or not. They may suggest you continue treatment if you are not having any bad side effects.

The trial team will ask you to fill out a questionnaire about 9 weeks after the start of your treatment and then every 6 weeks during your treatment. The questionnaire will ask about side effects and how you’ve been feeling.  This is called a quality of life study.

Hospital visits

You see the doctors and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood tests
  • An MRI scan or CT scan of your cancer, any cancer spread, chest, stomach and brain
  • Saliva test – this looks for microorganisms such as bacteria that live in your mouth to see if they have any association with how well your treatment works

The researchers will ask your doctor for a sample of your cancer that was removed when you had surgery or a biopsy Open a glossary item. If this is not possible, you will need to have a biopsy of your cancer in order to take part in the trial.

The researchers will use these samples to help them understand more about head and neck cancers and the reasons why some cancers respond to treatment and some do not.  For example, they will test for different biomarkers Open a glossary item including a test for a protein called PDl-1.

If you have mouth cancer, the researchers will test your cancer for the human papilloma virus (if you have not been tested for this before).  A type of HPV can help to cause some cancers in this area.

You visit hospital nearly every week, or every 2 weeks depending on your treatment. People in both treatment groups see a doctor and have blood tests every week or every 2 weeks. If you are having nivolumab, you have extra blood tests just before some of your treatments.

You have a further scan of your cancer, chest and stomach about 9 weeks after you have started treatment, then every 6 weeks as long as you are having treatment. You have a scan of your brain every 3 months until your treatment stops or your cancer starts to grow again.

You have another saliva test 7 weeks after the start of your treatment. During treatment, the trial team may ask to take another sample of your cancer. You do not have to agree to this if you don't want to. This part of the trial is optional.

When you finish treatment, you go to hospital to see a trial doctor 1 month and 2 months later. They will ask you how you are and you may have blood tests. You may have some of the tests that you had during treatment again.

The trial team would then like to contact you every 3 months to see how you are.  They may call you at home on the phone, or ask you to visit the hospital. The doctor may ask you to have further scans.

Side effects

As nivolumab is a new drug, there may be side effects we don’t know about yet. Possible side effects include

The most common side effects of methotrexate include

  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Sore mouth
  • Diarrhoea
  • Sensitive skin such as redness, rash and sensitivity to sunlight. During treatment, you can’t spend too long in the sun, and must cover up and use sunscreen on exposed areas.

We have more information about methotrexate.

The most common side effects of docetaxel include

We have more information about docetaxel.

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 Kevin Harrington

Supported by

Bristol-Myers Squibb
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 12216

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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