A trial comparing pembrolizumab and chemotherapy for head and neck cancer
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is comparing pembrolizumab with chemotherapy for head and neck cancer that has come back after treatment or spread elsewhere in the body.
Head and neck cancer includes
- Mouth and oropharyngeal cancer
- Laryngeal cancer
- Cancer in the part of the throat called the hypopharynx (throat cancer)
More about this trial
Doctors often treat head and neck cancer that has come back after treatment or spread elsewhere in the body with chemotherapy using 
. But sometimes the cancer continues to grow. In this situation doctors may use a different type of chemotherapy such as
In this trial they want to see if another type of drug called pembrolizumab would be better. Pembrolizumab is a type of biological therapy called a monoclonal antibody. It helps the immune system to kill cancer cells.
The aims of this trial are to find out
- If pembrolizumab is better than chemotherapy
- More about the side effects of pembrolizumab
- How treatment affects your day to day life
Who can enter
You may be able to join this trial if all of the following apply. You
- Have a head and neck cancer including mouth(oral) cancer, oropharyngeal cancer,
hypopharyngeal cancer, or laryngeal cancer that has come back after treatment, or has spread elsewhere in your body - Have a type of cancer called
squamous cell cancer - Have cancer that can be measured on a scan
- Are able to have a tissue sample (
biopsy ) taken. Sometimes tissue from a previous sample can be used but your doctor can advise you about this - Have had chemotherapy containing
platinum drugs in the past - Have satisfactory blood test results
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Are willing to use reliable contraception during treatment and for up to 6 months afterwards if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot join this trial if any of these apply. You
- Are able to have a treatment just to the area where your cancer is that could cure your cancer for example surgery or radiotherapy
- Have cancer that has come back within 3 months of completing treatment that the doctors hoped would cure your cancer
- Have had 3 or more cancer treatments that can reach your whole body (systemic treatment) since your cancer has come back or spread elsewhere in your body
- Are already taking part in a clinical trial or research study, or have had an experimental treatment in the last 4 weeks
- Have been diagnosed with a condition or have had a treatment that affects your immune system in the last 7 days. Certain steroid therapy may be allowed and your doctor can advise you about this
- Have had treatment with a monoclonal antibody in the last 4 weeks
- Have not recovered from any side effects due to having had a monoclonal antibody in the past
- Have had chemotherapy, other cancer drugs or radiotherapy in the last 2 weeks or you have not recovered from earlier treatment
- Have had previous treatment with any anti-PD1 or anti- PD2 drugs (your doctors can advise you about this)
- Have not recovered from any major surgery
- Have had a live vaccine in the last 30 days
- Have another type of cancer that needs treatment except for successfully treated non melanoma skin cancer or carcinoma in situ of the cervix
- Have cancer that has spread to your brain or spinal cord and is causing symptoms (you can take part if cancer spread to your brain was treated at least 4 weeks ago and is not causing symptoms)
- Have inflammation of the covering of the brain (carcinomatous meningitis) caused by your cancer
- Have a problems with your
immune system making you more likely to get infections - Have an
autoimmune disease and have had drugs that suppress the immune system in the last 3 months (some other types of drugs are allowed and your doctor can advise you) - Have a lung condition called pneumonitis
- Have an infection which needs treatment
- Have HIV, hepatitis B or hepatitis C
- Have any other medical condition or mental health problem that the trial team think could prevent you taking part
- Are pregnant or breastfeeding
Trial design
This is a phase 3 trial. The doctors need around 600 people to take part. 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 whether you have pembrolizumab or chemotherapy.
You have either
- Pembrolizumab
Or one of the following chemotherapy drugs
Your doctor decides which chemotherapy drug will be best for you. If you have already been treated with methotrexate, docetaxel or cetuximab since your cancer has grown or spread elsewhere in the body you will not be given these drugs again.
You have pembrolizumab as a drip into the vein once every 3 weeks. Each 3 week period is called a cycle of treatment. If you cope well with the treatment and your cancer does not grow then you could have treatment for up to 2 years.
If you have methotrexate or cetuximab, you have this as a drip into the vein once a week for 3 weeks. If you have docetaxel, you have this as a drip into a vein once every 3 weeks. Each 3 week period is one cycle of treatment. You will continue to have the treatment as long as it works and you can manage any side effects. Your doctor can advise you how long this is likely to be.
If your cancer continues to grow while you are having the trial treatment, you will stop that drug and have .
The trial team will ask you to fill out some questionnaires when you visit the hospital for the first 4 cycles of treatment. Then they ask you to complete them every 6 weeks and during follow up after you have finished treatment for up to 1 year. The questionnaires ask about side effects and how you’ve been feeling. These are called quality of life studies. You may be asked to fill this out using an electronic tablet like an I-pad.
The trial team will also ask to take a sample of tissue (a ). If it is not possible to do a biopsy they may be able to use a sample that has been taken in the past. The sample will be used in research to see how the drugs affect the cancer. If you have oropharyngeal cancer your doctor will also test the sample for Human Papillomavirus (HPV) if this has not been done before. They may also ask for extra blood samples for research.
Hospital visits
You will see the doctors and have some tests before you start treatment. The tests may include
- A tissue sample (
biopsy ) - Physical examination
- Blood tests
- Urine tests
- Heart trace (
ECG ) - CT or MRI scan
Depending on which treatment group you are in, you go to hospital either once every 3 weeks or once a week. At these visits you may have a physical examination and blood tests.
9 weeks after you start treatment you have a CT scan or an MRI scan. This is to see how well the treatment is working. After this you will have these scans very 6 weeks for the first year. Then you will have them every 9 weeks until your cancer gets worse. Your doctor may want you to have the scans more often. If this is the case they will discuss this with you.
After you finish treatment you see the trial team about a month later. Then you see them every 6 weeks for the first year and every 9 weeks after that until your cancer gets worse or you start a new cancer treatment. You may have some scans at these visits.
If your cancer gets worse, or you start a new cancer treatment, the trial team will contact you by telephone every 3 months to see how you are.
Side effects
Pembrolizumab is a new drug so not all the side effects may be known yet. The most common side effects of pembrolizumab are
- Tiredness and lack of energy (fatigue)
- Itchy skin
- Loss of appetite
- Shortness of breath
- Cough
The most common side effects of methotrexate are
- Sore mouth
- Feeling sick
- Tummy pain
- Diarrhoea (upset tummy)
- Tiredness and lacking energy (fatigue)
- Feeling shivery (chills)
- High temperature (fever)
- Dizziness
- A drop in red and white blood cells causing an increased risk of infection, tiredness and breathlessness
The most common side effects of docetaxel are
- A drop in red and white blood cells causing an increased risk of infection, tiredness and breathlessness
- Taste changes
- Changes to your sense of smell
- Infection
- High temperature (fever)
- Weight loss
- Difficulty swallowing
- Tummy cramps
- Heartburn
- Shortness of breath
- Constipation
- Loss of appetite
- Swelling of your hands, face or feet
- Tiredness and weakness (fatigue)
- Joint and muscle pain
- Feeling or being sick
- Diarrhoea
- Sore mouth
- Hair loss
- Skin rash
- Watery and red eyes
The most common side effects of cetuximab are
- A reaction to cetuximab when you have the drip, causing flu like symptoms such as a fever, chills and shivering (rigors), a headache and feeling sick. You will have anti allergy medicines beforehand to try to prevent a reaction
- Some kind of skin reaction (this may be a rash similar to acne on your face, neck and trunk or your skin may be dry and itchy)
- Tiredness
- Changes in blood pressure
- Twitchy muscles
- Rapid breathing or difficulty breathing
- Feeling or being sick
- Infection
- Headache
- Tummy pain
- Diarrhoea
- Weight loss
Dehydration
We have more information on
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.
Chief Investigator
Dr Martin Forster
Supported by
Merck, Sharp & Dohme Limited (MSD)
NIHR Clinical Research Network: Cancer
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
