A trial looking at AMG 319 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:

Head and neck cancers

Laryngeal cancer

Mouth (oral) cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at whether a new drug called AMG 319 is a useful treatment for people with certain types of head and neck cancer. It is for people with squamous cell cancer Open a glossary item of the

Hypopharynx
Oropharynx
Mouth
Supraglottis
Larynx (voicebox)

People must be due to have surgery for their head and neck cancer. Cancer Research UK supports this trial.

More about this trial

Doctors are looking at whether a new drug called AMG 319 can help the immune system Open a glossary item to attack cancer cells. Doctors have used AMG 319 for a small number of people with leukaemia and now they want to see if it will work in people with head and neck cancers.

AMG 319 is a type of biological therapy called immunotherapy. Immunotherapy uses substances produced by the body’s immune system. These substances help the body to fight infection and disease.

In the trial 1 group of people will have AMG 319.The other group will have a dummy drug (placebo). Everyone will then have surgery.

The aims of the trial are to

See how the drug affects your immune system and whether this affects your cancer
Learn more about the side effects of AMG 319
Understand how the drug works in your body

Who can enter

You may be able to join this trial if all of the following apply

You have squamous cell cancer of the hypopharynx, mouth, oropharynx, supraglottis or larynx (voicebox)
You are due to have surgery to remove your cancer
You have satisfactory blood test results
You are willing to use reliable contraception during the time of the trial and for up to 6 months afterwards if there is any chance you or your partner could become pregnant
You are aged 18 or older

If you have a head and neck cancer that has come back (recurred) or you have developed a 2nd tumour, you may still be able to take part in the trial if you had surgery only. You must have had your surgery at least 6 months before starting the trial.

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

Have already had treatment for your head and neck cancer apart from surgery
Have any other type of cancer that the trial doctors think could affect you taking part in this trial
Have had major surgery to your chest or tummy (abdomen) and you have not recovered
Have any disease, such as an infection, that affects your whole body and which is not controlled by medication
Have an autoimmune disease and you may need drugs that suppress the immune system during the time of the trial
Have a problem with the rhythm of your heart , the trial doctors can advise you about this
Take certain types of steroids or any type of drug that affects the rhythm of your heart, the trial doctors can advise you about this
Have HIV, hepatitis B or hepatitis C
Are taking part or plan to take part in another cancer treatment clinical trial
Have any other condition that the doctors think would affect your taking part in this trial

Trial design

This is a phase 2 trial. The doctors need around 54 people to join.

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. And neither of you will know which group you are in. This is called a double blind trial.

People in one group have AMG 319
People in the other group have a dummy drug (placebo)

You have a 2 in 3 chance of having AMG 319.

diagram_for_study.png

You start taking the AMG 319 or the dummy drug 20 to 29 days before you have your surgery. Both are capsules you take every day. Your doctor will tell how many. You will be given a diary card so you can write down when you take the drug and any problems you may have.

The doctors need to test a sample of your cancer (a biopsy Open a glossary item ) to look for the human papilloma virus (HPV) and for genes . You may have had a biopsy when your cancer was diagnosed. If so the doctors may be able to use a piece of this tissue. If not you will need to have a biopsy done. The doctors will tell you what this will involve.

Hospital visits

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

A physical examination
Blood tests
Urine tests
Heart trace (ECG )
MRI scan or CT scan
Biopsy

During treatment you see the doctor once a week for

Blood tests
Urine tests
Heart trace

You go to hospital on the 1st day of your treatment. Before taking the capsules you have some blood samples taken. The researchers will use these samples to see what happens to AMG 319 in your body. This is called pharmacokinetics. Open a glossary item You may also have some urine tested.

During your second visit you have a tetanus vaccination Open a glossary item unless you have had a booster in the last 6 months. You have this vaccination to see if the AMG 319 affects how your immune system responds to the vaccine. You have some blood samples taken before you have the capsules and again 4 hours afterwards.

On your 3rd visit you have more blood samples taken before you have the capsules and again 4 hours afterwards.

You have an MRI scan or CT scan in the 3 days before or on the day of your surgery. This is to see if the size of your cancer has changed since starting treatment.

You finish taking AMG 319 the day before your surgery. You see the doctor 60 days after surgery for

Blood tests
Urine test
Heart trace

If you are starting chemotherapy or radiotherapy after your surgery you will have this visit before you start this treatment.

If you have any side effects from AMG 319 the doctors will continue to see you until they have stopped. Otherwise they will continue to collect information about you when you go to hospital for routine follow up after your surgery or after any additional treatment you have.

Side effects

Because AMG 319 is a new drug there may be some side effects which we don’t know about yet. Part of the trial is looking at the side effects of this drug and you will be given a telephone number so you can call the trial team if you are worried about anything.

The most common side effects of AMG 319 are

Diarrhoea
High temperature (fever)
Feeling sick
Tummy (abdominal) pain
Low red and white blood cells causing an increased risk of infection, tiredness and breathlessness
Skin rash
Flu like symptoms