A study of nivolumab and usual treatment for mouth cancer (NICO CA209-891)

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

Cancer type:

Head and neck cancers

Mouth (oral) cancer

Status:

Closed

Phase:

Phase 2

This study is looking at adding nivolumab to chemoradiotherapy or radiotherapy for cancer of the mouth.

It is for people whose cancer has spread to nearby tissues or lymph nodes Open a glossary item but hasn’t spread elsewhere in the body.

More about this trial

The usual treatment for mouth cancer, is surgery. After surgery, you might have radiotherapy alone or with chemotherapy (chemoradiotherapy). This is to kill any cancer cells that might have been left behind. And lower the risk of the cancer coming back.

But sometimes the cancer does come back. So, doctors are looking for ways to improve treatment. In this study, they are looking at a drug called nivolumab.

Nivolumab is a type of immunotherapy. It stimulates the body’s immune system Open a glossary item

to fight cancer cells.

The main aims of this study are to find out:

whether adding nivolumab to usual treatment prevents the cancer coming back
more about the side effects
how it affects quality of life

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if all of the following apply.

You:

have squamous cell cancer of the mouth
have cancer that may have spread to surrounding tissue or nearby lymph nodes but hasn’t spread elsewhere in the body
are willing to give a new tissue sample or there is one available for the study team to do some tests on
have surgery planned to remove the cancer
have satisfactory blood test results
are able to carry out all your daily activities apart from heavy physical work (performance status 0 or 1)
are willing to use reliable contraception during treatment and for 5 months afterwards if you are a woman and for 7 months afterwards if you are a man if there is any chance you or your partner could become pregnant
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply.

You:

have cancer that has grown into the bone only and you don’t have cancer in nearby lymph nodes
have cancer that has spread elsewhere in the body
can’t have chemoradiotherapy due to other medical conditions
have already had radiotherapy to the head and neck
have had another cancer in the past 3 years apart from non melanoma skin cancer or early cancer called carcinoma in situ . You might be able to join if you had head and neck cancer within the last 3 years and the only treatment you had was surgery and you didn’t need radiotherapy.
are having treatment to dampen down your immune system
have an autoimmune disease unless it is vitiligo, type 1 diabetes, hair loss (alopecia), thyroid problems that are controlled by medications or a skin condition called psoriasis that doesn’t need treatment
have HIV
have an active hepatitis infection
are pregnant or breastfeeding
have any other medical condition or mental health problem that the study team think would affect you taking part

Trial design

This is a phase 2 study. It is taking place in the UK. The researchers need 120 people to join.

You have treatment as follows:

1 dose of nivolumab before surgery (dose 1)
surgery 1 to 2 weeks later
1 dose of nivolumab a week or 2 before having chemoradiotherapy or radiotherapy (dose 2)
chemoradiotherapy or radiotherapy
6 doses of nivolumab (dose 3 to 8) – you have these every 4 weeks

15705-flow-chart.png

Nivolumab

You have 8 doses of nivolumab over a period of 8 to 10 months. You have nivolumab as a drip into a vein. It takes about an hour each time.

Surgery

You have surgery to remove the cancer. Your doctor will tell you more about this and how long you stay in the hospital for afterwards.

Radiotherapy or chemoradiotherapy

Depending on the results of your surgery, your doctor will recommend if you should have radiotherapy or chemoradiotherapy.

You have radiotherapy once a day (Monday to Friday) for 6 weeks. It takes about 10 to 15 minutes each time.

Those having chemotherapy have cisplatin. You have it twice while you are having radiotherapy. You have it as a drip into a vein.

Quality of life

The study team will ask you to fill out a questionnaire before you start treatment and at set times during treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study Open a glossary item

Samples for research

The study team will ask you to give some extra blood samples during treatment. You give the samples at specific times and the study team will give you more information about this. They plan to use the samples to:

see how well treatment is working
predict who might benefit most from treatment

Hospital visits

You’ll see a doctor and have some tests before you can take part. These include:

physical examination
blood samples
urine samples
heart trace (ECG)
CT scan or MRI scan

You have all your treatment at the hospital.

After surgery you have a CT scan or MRI scan and a check up with the study doctor at:

6 months
9 months
1 year

Side effects

Having nivolumab with radiotherapy and chemotherapy is a new combination of treatment. So, there might be some side effects we don’t know about yet. The study team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything.

The most common side effects of nivolumab are:

tiredness (fatigue)
skin problems such as rash, itching, hives, redness and dry skin
dry or inflamed mouth
loss of appetite
feeling or being sick
fever or chills
cough
inflammation of the lung (pneumonitis)
tummy pain
stiff or painful joints
tingling, burning, numbness or weakness of the arms, legs, hands or feet
headache
shortness of breath
diarrhoea or constipation
swelling of the face, arms or legs
thyroid gland changes

This treatment affects the immune system. This may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment, or some months after treatment has finished. In some people, these side effects could be life threatening.

The most common side effects of radiotherapy include: