A trial looking at atezolizumab for people with 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

Pharyngeal cancer

Status:

Closed

Phase:

Phase 3

This trial is for people with cancer of the:

mouth (oral cavity)
oropharynx
hypopharynx
larynx

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It is for people who have completed initial treatment for their head and neck cancer and have a high risk of the cancer coming back or getting worse.

More about this trial

The main treatment for head and neck cancer includes:

surgery
radiotherapy
chemotherapy and radiotherapy (chemoradiotherapy)

For some people, this is the only treatment they need. But sometimes, the cancer can get worse or come back after the main treatment.

In this trial, doctors want to find out if a drug called atezolizumab can help to stop head and neck cancer from coming back after treatment.

Atezolizumab is a type of immunotherapy. It works by blocking a protein called PD-L1 which stops the immune system from working properly. Atezolizumab is already a possible treatment for people with some types of lung and bladder cancer.

Everyone taking part in this trial has one of the following after their main treatment:

atezolizumab
dummy drug (placebo)

The main aim of this trial is to find out how well atezolizumab works for people with head and neck cancer.

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:

you have advanced squamous cell carcinoma (SCC) of the head and neck - the oral cavity, oropharynx, larynx, or hypopharynx
your cancer has been tested for the human papilloma virus (HPV)
you have finished the main treatment for head and neck cancer
your cancer stayed the same, got better or disappeared after the main treatment
you have had scans of your chest and tummy (abdomen) in the last month and these scans showed that you don’t have cancer outside the head and neck area.
you are well enough to carry out your normal activities apart from heavy physical work (performance status of 0 or 1)
you have satisfactory blood test results
are at least 18 years old
if you are a woman, you are willing to use reliable contraception during treatment and for 5 months afterwards if there is any possibility that you could become pregnant

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
your cancer has spread to other parts of your body
you have had surgery or radiotherapy on its own as the main treatment for your cancer
your cancer got worse (progressed) during treatment
you have had treatment with atezolizumab or any other similar drug

Medical conditions

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

have high levels of calcium in your body that isn’t controlled
have an autoimmune disease, unless it is a thyroid problem that is controlled with medication, type 1 diabetes, a condition where white patches develop on the skin (vitiligo) or other skin conditions called eczema and psoriasis
have heart problems such as angina that isn’t stable, an abnormal heart rhythm (arrhythmia) or you have had a heart attack in the last 3 months
have taken drugs that damp down your immune system (immunosuppressants) such as steroids in the past 2 weeks, unless it was a very small dose
have had treatment with drugs that have an effect on the immune system such as interferon in the last month
have active tuberculosis
have HIV
have hepatitis B or hepatitis C
have had an organ or stem cell transplant from a donor

Other

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

have had a live vaccine in the last month, or you need to have a live vaccine within 5 months of your last atezolizumab treatment
are sensitive to atezolizumab or anything it contains
are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. Doctors hope that around 400 people worldwide and up to 10 people from the UK will agree to take part.

It is a randomised trial. The people taking part are put into 1 of the following treatment groups by computer:

atezolizumab
dummy drug

Neither you nor your doctor are able to decide which group you are in. And neither you nor your doctor will know which group you are in. This is a double blind trial.

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You have atezolizumab or the dummy drug as a drip into your bloodstream (intravenously) every 3 weeks. It takes between 30 to 60 minutes each time you have it.

You continue to have treatment for as long as there are no signs of your cancer coming back or getting worse, and the side effects aren’t too bad. You can have up to 16 treatments or up to 1 year of treatment (whichever happens first).

Quality of life

Everybody taking part in this trial completes a quality of life questionnaire before the start of treatment and:

every 3 weeks during treatment
a month after finishing treatment
then every 3 months

The questionnaires ask about how you have been feeling and the side effects you have had. It takes about 15 minutes to complete each questionnaire.

Blood tests

You have some extra blood tests as part of this trial. Researchers want to:

look for certain substances (biomarkers) that can help to tell how well the treatment works
find out what happens to atezolizumab in your body

You have the extra blood tests every time you have atezolizumab or the dummy drug, and a month after finishing treatment.

Tissue sample

You might need to have a tissue sample of your cancer taken (biopsy) before the start of your treatment. Doctors want to:

look for certain substances (biomarkers)
check whether your cancer has the human papilloma virus (HPV)

You don’t need to have a biopsy if there is a suitable sample available from when you were diagnosed, or that was taken during surgery.

The trial team might also ask you to have a biopsy if your cancer gets worse or comes back. You don’t need to agree to have this if you don’t want to. You can still take part in this trial.

Hospital visits

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

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

During treatment, you see the trial team every 3 weeks. You have blood tests and a physical examination every time you see them.

You have scans regularly to check how your cancer is responding to the treatment. This continues until your cancer comes back, gets worse or until you decide to leave the trial.

When you finish treatment, you see the trial team after a month. You have tests such as blood tests and a physical examination. You then see or speak with the trial team every 3 months. This continues for up to 5 years.

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call if you are worried about anything. The team will tell you about all the possible side effect before you start the trial.

Atezolizumab has an effect on 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. In some people, these side effects can be life threatening.

The most common side effects of atezolizumab are: