A trial looking at monalizumab for head and neck cancer that has spread or come back (INTERLINK 1)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at adding monalizumab to cetuximab for people who have 
of the head and neck.
The trial is open to people whose cancer has come back or spread to another part of the body.
It is for people who have one of the following types of head and neck cancer:
- mouth and oropharyngeal cancer
- cancer of the area that surrounds the voice box (
hypopharynx ) - cancer of the voice box (laryngeal cancer)
More about this trial
Researchers are looking for ways to improve treatment for people who have cancer of the head and neck. In this trial they are looking at monalizumab and cetuximab.
Monalizumab is a type of . It stimulates the body's immune system to fight cancer cells.
Cetuximab is a for some types of head and neck cancer that has spread or come back. It is a type of called a monoclonal antibody. It looks for cancer cells by targeting particular proteins on the cell surface.
Researchers think that cetuximab and monalizumab together might work well to treat head and neck cancer. They aren’t sure so want to find out more.
In this trial some people have monalizumab and cetuximab. And some have cetuximab and a dummy drug ().
The main aims of this trial are to find out:
- how safe it is to have monalizumab and cetuximab
- how well this combination works
- how treatment affects
quality of life
Who can enter
The following bullet points are a summary of 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 you have one of the following types of head and neck cancer:
- mouth and oropharyngeal cancer
- cancer of the area that surrounds the voice box (
hypopharynx ) - cancer of the voice box (laryngeal cancer)
And all of the following must also apply. You:
- have cancer that is
squamous cell cancer - have cancer that got worse during or after treatment and you can’t have treatment with the aim to cure
- have had a
platinum drug in the past but your cancer either got worse or came back during or after treatment - have had 1 or 2 treatments for cancer that reaches the whole body (
systemic treatment ) for cancer that has come back or spread - have had a type of drug called a PD-L1 inhibitor in the past such as nivolumab or pembrolizumab
- have at least one area of cancer that the doctor can see and measure on a scan
- gave a recent tissue sample or you are willing to give a new sample for the trial team to do some tests on
- have cancer that has been tested for the
human papilloma virus (HPV) if you have mouth cancer or cancer of the back of the mouth (oropharyngeal cancer) - have satisfactory blood test results
- weigh more than 30 kg
- are active and can look after yourself but might not be able to do heavy physical work (performance status 0 or 1)
- are willing to use reliable contraception during treatment and for a period after if there is any chance you or your partner could become pregnant
- are willing not to donate blood while taking part in this trial and for a period after
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have nasopharyngeal cancer, salivary gland cancer or your doctors don’t know where your cancer started (cancer of unknown primary)
- are having another treatment for cancer
- had the last dose of treatment for cancer in the month before starting treatment in this trial. This includes having chemotherapy,
immunotherapy , a targeted cancer drug , tumour embolization , a monoclonal antibody drug an experimental treatment or radiotherapy with the aim to cure to more than 30% of the bone marrow or to a large area of your body - have had monalizumab in the past
- have cancer that has spread to your brain or spinal cord unless you have had treatment and there are no signs of it getting worse
- have had cetuximab in the past. You may be able to join if you had it in combination with radiotherapy with the aim to cure cancer spread in the surrounding tissues. Your doctor will know about this.
- have side effects from past cancer treatments unless they are mild. You can take part if you have hair loss or white patches on your skin (vitiligo).
- have had another cancer that got worse or needed treatment in the past 5 years. You may be able to take part if the other cancer has a low chance of coming back. You can take part if you had successfully treated
non melanoma skin cancer , very early melanoma skin cancer, a very early cancer called carcinoma in situ (CIS ) or early prostate cancer that is being monitored but you aren’t having treatment. - have taken part in a clinical trial using an experimental treatment in the last 30 days. You may be able to take part if the other trial isn’t a treatment trial.
Medical conditions
You cannot join this trial if any of these apply. You:
- have a significant
heart problem that needs treatment. The trial team check if you have a heart condition before you join the trial. - have had treatment that damps down the
immune system This includes having steroids within 2 weeks of starting trial treatment unless it was a low dose. - have a problem with how your immune system works
- have a blood transfusion within 120 days of giving a tissue sample looking at genes
- have had major surgery in the last month. You may be able to take part if you had surgery to help with cancer symptoms.
- have had an
organ transplant or a bone marrow transplant in the past - have an
autoimmune condition that needs treatment or you have had treatment in the past. This is apart from certain ones. Your doctor will know this. - have an inflammatory condition such as
ulcerative colitis or Crohn’s disease - have scarring of the lungs. This is called interstitial lung disease.
- have HIV, an active hepatitis B or hepatitis C infection, active tuberculosis (TB) or any severe infection that needs treatment
- have another medical condition or mental health problem that your doctor or the trial team think could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- are allergic to cetuximab and monalizumab or anything they contain
- have had a live
vaccination within a month of having the first dose of trial treatment or will have one soon after treatment. Please note that the current approved COVID-19 vaccines are not live. - are pregnant or breastfeeding
Trial design
This phase 3 trial is taking place worldwide. The trial team need 624 people to take part including 20 people from the UK.
It is a randomised trial. You are put into a group by a computer. Neither you nor your doctor will be able to decide which group you are in. Nor will either of you know which group you are in. The trial team can find this out if necessary.
There are 2 treatment groups. You have 1 of the following:
- cetuximab and monalizumab
- cetuximab and the dummy drug (
placebo)
2 out of every 3 people have cetuximab and monalizumab. And 1 out of every 3 people have cetuximab and the dummy drug.
You have all your treatment as a drip into a vein.
You have monalizumab or the dummy drug once every 2 weeks. It takes about an hour each time.
You have cetuximab once a week. The first dose takes 2 hours. Each dose after that takes about an hour.
You have treatment for as long as it is working and the side effects aren’t too bad. You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Samples for research
The researchers ask you to give some extra tissue samples. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.
The team plan to use the samples to:
- see how well treatment is working
- look at
genes in the cancer cell to understand more about your cancer type - see what happens to treatment in the body
- see if your cancer is developing resistance to trial treatment
- look for substances called
biomarkers to help work out why treatment might work for some people and not for others
You need to agree to give most of the samples to take part in the trial. There are a few tissue samples you can say no to. This won’t affect you taking part in the rest of the trial. The team can let you know more about this.
Quality of life
The trial team ask you to fill out a questionnaire:
- before you start treatment
- at set times during treatment
The questionnaire asks about side effects and how you’ve been feeling. This is called a quality of life study
Hospital visits
You see the doctor and have tests before you can take part. These include:
You have treatment at the hospital on the day care ward. You see the doctor at each visit for a check up and have some blood tests.
Some hospital visits take about 3 hours but others can take much longer. This depends on the tests or scans that you are having. The team can give you a better idea of how long each visit will be.
You have a CT scan or an MRI scan:
- every 8 weeks for the first year and then
- every 3 months
If you have cancer spread to the brain you have another brain scan a month after you join the trial.
You stop having all the trial scans if your cancer gets worse.
When you finish treatment you see the doctor 1 month later for a check up.
Follow up
After treatment you have a check up at the hospital once a month for 3 months. They might then see you at routine hospital appointments. This is until the cancer gets worse or you start another cancer treatment.
If your cancer gets worse or you start another cancer treatment the team then call you about every 2 months. This is to see how you are getting on.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The combination of monalizumab and cetuximab is a new treatment. So there may be possible side effects we don’t know about yet.
| Monalizumab can affect the immune system. It may cause inflammation in different parts of the body. This can cause serious side effects. They could happen during treatment, or some months after treatment has finished. Rarely, these side effects could be life threatening. If you have any of these side effects tell your doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy. |
The possible side effects of monalizumab we know about so far are:
- tiredness (fatigue)
- feeling or being sick
- having an allergic reaction during treatment
- having a flu like or allergic reaction soon after or within a few hours of treatment
Symptoms of an allergic reaction include flushing, skin rash, fever, chills or shortness of breath. Severe reactions can cause breathing problems, low blood pressure and heart problems. This is an emergency and needs urgent treatment.
The team keep a close eye on you during treatment and afterwards. They will treat any problems straight away.
Please note, bleeding can be a common problem in people with head and neck cancer. The researchers don’t know if the risk of bleeding will be higher or lower with monalizumab and cetuximab than with cetuximab alone. Please talk to your trial doctor immediately if you have any bleeding problems.
We have information about cetuximab and its side effects.
The trial doctor will talk to you about all the possible side effects of treatment. You will have a chance to ask any questions you may have.
Other medications
Please tell your trial doctor if you are taking any medications that might increase your risk of bleeding. These include aspirin, blood thinners, or certain types of pain medications called NSAIDs (). Your trial doctor may suggest that you stop taking these medications while you are having trial treatment.
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.
Chief Investigator
Professor Kevin Harrington
Supported by
AstraZeneca
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
