A trial of BNT113 for head and neck cancer (AHEAD-MERIT)

Cancer type:

Head and neck cancers

Status:

Open

Phase:

Phase 2

Please note - the trial team have asked us to base this summary on the information available on https://clinicaltrials.gov. There is less detail than we would usually include and it hasn't been checked by them.

This trial is comparing BT113 and pembrolizumab to pembrolizumab alone, for squamous cell Open a glossary item head and neck cancer.

It is for people who have cancer that:

has come back after other treatment or has recently spread to another part of the body
cannot be removed with an operation
is linked to a virus called human papillomavirus type16 (HPV16)
has lots of a protein called PD-L1 (is PD-L1 positive)

More about this trial

Some head and neck cancers are caused by a virus called HPV16. They are called HPV16 positive cancers.

BNT113 is a type of targeted cancer drug called a cancer vaccine. It finds proteins that are often contained within HPV16. This helps the immune system Open a glossary item recognise and kill cancer cells.

This trial is for people with cancer of the oropharynx, mouth, hypopharynx or larynx. It is not open to people who have cancer of the nasopharynx.

Diagram for trial

The main aims of the trial are to find out:

more about the side effects of BNT113
how well it works for HPV16 positive head and neck cancer
what effect it has on people’s 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 all of the following apply. You:

have squamous cell cancer of the oropharynx, mouth, hypopharynx or larynx
have cancer that has come back after treatment or spread to another part of the body (metastasised)
have not had treatment since your cancer has grown or spread
have cancer that is HPV16 positive and has the PD-L1 protein
have an area of cancer that the doctors can see and measure on scan
have satisfactory blood test results
have a sample of tissue (biopsy ) available for the trial team to do some tests on, or you are willing to have a new sample taken
are at least 18 years old
are willing to use reliable contraception during treatment and for a at least 6 months afterwards if there is any chance that you or your partner could become pregnant
are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)

Who can’t take part

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

are able to have treatment aimed at curing your cancer
have cancer of the nasopharynx
have cancer that has spread to your brain or spinal cord recently and is growing. You may be able to take part if you’ve had treatment, it is stable and you don’t have any symptoms.
have had treatment for your cancer since it’s come back or spread
have had cancer treatments which work by changing your immune system recently. Your doctor can tell you more.
have had radiotherapy or surgery in the 2 weeks before you join the trial
are still having side effects from treatment, apart from some such as hair loss or numbness and tingling (neuropathy)
are allergic to either of the treatments used in the trial
have had treatment as part of another clinical trial recently
have had a stem cell transplant using someone else’s cells
have had another cancer, unless you had treatment and there have been no signs of cancer in the last 2 years. You may be able to join if you had carcinoma in situ of the cervix, non melanoma skin cancer , early stage prostate or bladder cancer, or ductal carcinoma in situ of the breast.

Other medical conditions

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

have had a major operation in the 4 weeks before you join the trial, have not fully recovered from surgery you have had, or are due to have surgery
have an infection which needs treatment
have serious heart problems such as congestive heart failure, an abnormal heart rhythm or have had a heart attack in the 3 months before joining the trial
have had a blood clot (thrombosis or embolism) in the 6 months before joining the trial. You may be able to take part if you are on a stable dose of blood thinning medication (anticoagulants) and your doctor thinks it will be safe for you to do so.
have lung problems such as scarring (interstitial lung disease) or inflammation (pneumonitis) not caused by an infection
have high blood pressure which is not controlled with medication
have problems with your immune system not working properly, have an autoimmune condition or are taking medication to supress your immune system. This includes some steroid treatment. Your doctor can tell you more.
have had treatment similar to BTN113 recently or had serious side effects or are still having certain side effects from similar treatment. Your doctor can tell you more.
have HIV, unless it is well controlled and you are on a stable dose of anti viral medication
are taking antibiotics, unless it is long term preventative treatment
have had your spleen removed
have had an organ transplant
have hepatitis B or hepatitis C
have any other serious medical condition or mental health condition that the trial team think could affect you taking part

Other

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

are pregnant or breastfeeding
recently had a live vaccine (the approved COVID-19 vaccines as are not live)
work for, or are closely related to someone who works for, the hospital or company running the trial. You may be able to have this looked at by a review board.

Trial design

This is a phase 2 trial taking place in several countries around the world. The research team hope to find 285 people to join the trial in total.

It is being done it 2 parts.

Part A is being done to find out more about side effects. Everyone joining part A will have both BNT113 and pembrolizumab.

Part B is being done to find out more about how well BNT113 works. As well as finding out more about the side effects.

The people in part B part are put into 1 of 2 treatment groups at random:

half will have BNT113 and pembrolizumab
half will have pembrolizumab on its own

Neither they nor their doctor can decide which group they are in.

Hospital visits

You will see the trial team and have some tests before you start treatment. These will include scans and blood tests.

We don’t have any more details about this, the trial team will be able to tell you more.

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.

We have more information about cancer vaccines and pembrolizumab in our Cancer drugs section.

Location

Cardiff

Glasgow

Liverpool

London

Nottingham

Oxford

Southampton

Sutton

Early results

In 2022, the research team published some early results about the side effects of BNT113 so far in this trial. At the time, 15 people in part A had had treatment.

This showed that the most common side effects were a temperature and chills. There is more information about this in the ‘other information’ section below.