A trial looking at avelumab and cetuximab for people with head and neck cancer (EACH)

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

Cancer type:

All cancer types

Head and neck cancers

Laryngeal cancer

Mouth (oral) cancer

Pharyngeal cancer

Status:

Closed

Phase:

Phase 2

This trial is for people whose cancer has come back or spread to other parts of the body.

More about this trial

Targeted drugs are a common treatment for people whose cancer came back (recurrent) or spread to other parts of the body (metastatic).

Avelumab and cetuximab are both a type of targeted drug called a monoclonal antibody. They seek out cancer cells by targeting particular proteins on the cell surface.

Avelumab is already a possible treatment for people with a type of skin cancer called Merkel cell carcinoma. Cetuximab (Erbitux) is a treatment for some types of head and neck cancer.

This trial was in 2 parts. The first part is called a safety run in. Doctors were looking for people with different types of squamous cell carcinoma (SCC) to join this part. They gave treatment to a few people at a time so that they could check the side effects and the best dose of cetuximab and avelumab.

The trial closed earlier than planned so part 2 didn’t go ahead.

The main aims of this trial were to:

find the best dose of cetuximab and avelumab
learn more about the side effects of treatment
find out how well cetuximab and avelumab work as a treatment for squamous cell carcinoma

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.

Who can take part
You may be able to join this trial if all of the following apply:

doctors think you can’t have treatment to try to cure your cancer
you have at least one area of cancer that can be seen and measured on a scan
you have satisfactory blood test 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)
you are willing to use reliable contraception during treatment and for 6 months afterwards if there is any possibility that you or your partner could become pregnant

As well as all of the above, the following must also apply for you to be able to join the first part of this trial (safety run in):

you have cancer that developed from squamous cells (squamous cell carcinoma)
your cancer has come back or spread to other parts of the body

The following must also apply for you to be able to join the 2nd part of this trial:

you have squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, or hypopharynx)
your cancer has come back or spread to other parts of the body
you have had treatment with cisplatin or carboplatin
you are willing to have a sample of tissue taken (biopsy )

Who can’t take part
You cannot join this trial if any of these apply.

Cancer related

your cancer started in the nasopharynx or paranasal sinuses
you have cancer spread in your brain, spinal cord or the thin layers of tissue that cover your brain (carcinomatous meningitis) unless you have had treatment, it has been stable for the past month and you have stopped taking steroids more than a week ago
you have had avelumab, cetuximab or any other similar drug
you have had a monoclonal antibody in the last month
you have had chemotherapy or radiotherapy in the past 2 weeks
you still have moderate or severe side effects from previous anti cancer treatment, apart from hair loss or any other moderate side effect that doctors think won’t affect you taking part
have another cancer that doctors think could affect you taking part in this trial

Medical conditions
You cannot join this trial if any of these apply. You:

are taking part in another clinical trial or have taken part in a trial looking at a new drug or device in the last month
have severe problems with your nerves that can cause numbness and tingling in fingers and toes
take or have taken drugs that damp down your immune system such as steroids in the past week unless it was a very small dose
have heart problems such as an abnormal heart rhythm, congestive heart failure, angina that isn’t stable or you have had a heart attack in the last 6 months
have inflammation of your bowel (colitis)
have eye problems such as inflammation of the white part of your eyes (cornea) or dry eyes
have or have had lung problems such as pneumonitis that needed treatment with steroids or scarring (fibrosis) of the lungs
have an autoimmune disease unless it is a skin condition called vitiligo or psoriasis, or problems with your thyroid that are stable
have HIV
have hepatitis B or hepatitis C
have had an organ transplant from a donor
have an active infection that needs antibiotics that reach your whole body (systemic)
have any other serious medical condition or mental health problem that the trial team think could affect you taking part

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

are pregnant or breastfeeding
have had a live vaccine in the last month
are sensitive to any of the drugs used in this trial or anything they contain

Trial design

This was a phase 2 trial. 16 people joined part 1. The team had hoped to recruit people to join part 2 but the trial closed early.

Everyone taking part had treatment in cycles of treatment that lasted 4 weeks. The first day of each cycle is called day 1.

Part 1
Everyone taking part had avelumab and cetuximab. The first few people taking part had the recommended dose of cetuximab and avelumab. They didn’t have any serious so everyone continued on this dose.

You have avelumab and cetuximab as drips into your bloodstream. It takes between 2 to 3 hours to have cetuximab each time. And about an hour to have avelumab. You have both drips on day 1 and day 15 of each treatment cycle.

This continued for as long as it was working and the side effects weren’t too bad. You can have treatment for up to a year.

Part 2
The plan was to open part 2 once doctors had checked the best dose of avelumab and cetuximab in part 1. Part 2 was going to look at treatment only for people with SCC of the head and neck.

Some people were going to have cetuximab and avelumab and some were going to have avelumab on its own.

But this part of the trial didn’t go ahead and the trial closed earlier than planned.

Blood tests
You might have extra blood tests as part of this trial. You have them before the start of treatment and then:

on day 15 of your first treatment cycle
before your 3rd treatment cycle
when you finish treatment
if your cancer comes back

Researchers want to look for certain proteins (biomarkers Open a glossary item ) that can help to tell how well the treatment is working. You don’t have to agree to have extra blood tests if you join part 1 of this trial.

Tissue sample
The trial team will ask to use a tissue sample of your cancer taken when you had surgery or a biopsy. If you join the 2nd part of this trial, you also need to give a new tissue sample of your cancer (biopsy) before the start of treatment.

Doctors may also ask you to give new tissue samples at set times during this trial. You don’t have to agree to this if you don’t want to. You can still take part in this trial.

Diary
The trial team will give you a diary for you to complete during treatment. You write down the side effects you have and any medicines you take.

You need to bring the diary with you every time you go into hospital.

Hospital visits

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

a physical examination
blood tests
urine test
a CT scan or MRI scan

During treatment, you see the trial team every 2 weeks. You have blood tests and a physical examination every time you see them.

You have a CT scan or MRI scan every 8 weeks. This continues for as long as the treatment is helping you and the side effects aren’t too bad.

When you finish treatment, you see the trial team every 4 weeks, for 3 months. You have blood tests and a physical examination every time you see them. You then see or speak with the trial team every 3 months.

Side effects

The trial team monitor you during treatment and afterwards. 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 treatment.

Avelumab and cetuximab affect the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. Side effects can happen during treatment or some months after treatment has finished.

The most common side effects of avelumab are:

tiredness (fatigue)
loss of appetite
feeling or being sick
loose or watery poo (diarrhoea)
skin rashes and itching
an allergic reaction during the infusion
pain in your joints and stomach
headaches
inflammation of your bowel (colitis)
low levels of thyroid hormones in your body causing tiredness, weight gain and feeling cold

The most common side effects of cetuximab are:

an allergic reaction during the infusion which can cause swelling of the lips, face or throat, breathing difficulties, fever and chills
skin and nail changes such as skin rash, itching, dry skin and inflammation around the fingernails or toenails
loose or watery poo
feeling or being sick
stomach pain

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