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

Cancer type:

Head and neck cancers
Mouth (oral) cancer

Status:

Open

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 Open a glossary item

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 Open a glossary item but hasn’t spread elsewhere in the body 
  • are willing to give a new tissue sample Open a glossary item 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 Open a glossary item 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 Open a glossary item or early cancer called carcinoma in situ Open a glossary item. 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 Open a glossary item 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 

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 Open a glossary item (ECG)
  • CT scan or MRI scan
You have all your treatment at the hospital. 
 
You have a CT scan or MRI scan and a check up with the study doctor at:
  • 4 months
  • 8 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 Open a glossary item 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:
The very common side effects of cisplatin include:
  • a drop in blood cells causing an increased of infection, bleeding problems, tiredness and breathlessness
  • high temperatures (fever)
We have information about:

Location

Liverpool

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Joe Sacco

Supported by

Bristol-Myers Squibb
Clatterbridge Cancer Centre NHS Foundation Trust

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15705

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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