A trial looking at V940 and pembrolizumab to improve treatment for squamous cell skin cancer (INTerpath-007)

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

Cancer type:

Skin cancer

Status:

Closed

Phase:

Phase 2/3

This trial is looking at 2 drugs called V940 and pembrolizumab for locally advanced Open a glossary item squamous cell skin cancer. 

The trial is for people who:

  • have cancer that has spread into the surrounding tissues and it is possible to treat it with surgery
  • have not had systemic Open a glossary item cancer treatment

More about this trial

The usual treatment for squamous cell skin cancer that has grown into surrounding tissues is surgery. You might also have radiotherapy afterwards. This is standard treatment Open a glossary item. Sometimes the cancer comes back or spreads. So doctors are looking at treatment to stop this happening. 

In this trial, they are looking at 2 drugs called V940 and pembrolizumab.

Pembrolizumab is an immunotherapy Open a glossary item. It works by helping the immune system Open a glossary item to find and kill cancer cells. It is already a treatment for some types of cancer. 

V940 is an immunotherapy. It is also called mRNA-4157. To make it, doctors analyse tissue and blood samples from each person's cancer. Using this information, V940 is made just for you. This teaches your immune system to find and target the cancer at its earliest stages. 

In this trial, some people have standard treatment. Some people have standard treatment and pembrolizumab. And some people have standard treatment, pembrolizumab and V940. 

The main aims of the trial are to find out:

  • which treatment works best 
  • how safe it is to have V940, pembrolizumab and standard treatment 
  • how safe it is to have pembrolizumab and standard treatment 
  • more about the side effects 
  • how treatment affects quality of life Open a glossary item 

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 skin cancer (SCC) Open a glossary item that started in the skin (the primary site). You can’t take part you have SCC of the penis, scrotum Open a glossary item, vulva Open a glossary item or around the anus Open a glossary item.
  • can have surgery to remove the cancer with the aim to cure 
  • have cancer that measures at least 2cm across. The cancer may have spread to lymph nodes Open a glossary item or into surrounding tissues but it hasn’t spread to other parts of the body.
  • have a sample of cancer tissue that is suitable for the trial team to use 
  • have cancer that your doctor can measure on a scan 
  • have satisfactory blood test results 
  • are fit and active but might not be able to do heavy physical work (performance status of 0 to 1) 
  • are willing to use reliable contraception during the trial and for a period after if you have pembrolizumab or V940 and could become pregnant. For those who have radiotherapy, you must be willing to use reliable contraception during the trial if you or your partner could become pregnant.
  • are willing not to donate sperm or eggs during the trial and for a period after if you have pembrolizumab, V940 or radiotherapy 
  • 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 another type of skin cancer or you have a mixed type of skin cancer. This could include basal cell cancer Open a glossary item that has not been treated with surgery or radiotherapy, a very early skin cancer (Bowen’s disease), Merkel cell skin cancer or melanoma skin cancer. Your doctor will know this.
  • have cancer that has spread to another part of the body or to distant lymph nodes  
  • have had cancer that has spread to the brain or spinal cord or the membrane that covers them
  • have had immunotherapy Open a glossary item or certain checkpoint inhibitors Open a glossary item in the past. Your doctor will know this.
  • have had a cancer vaccine Open a glossary item in the past 
  • have had radiotherapy within 2 weeks of starting trial treatment or you still have side effects of radiotherapy that need steroid treatment Open a glossary item
  • have already had cancer treatment for SCC before you are put into a treatment group. This includes experimental treatment. 
  • have had a red blood cell Open a glossary item transfusion, platelet Open a glossary item transfusion or a treatment that encourages white blood cells Open a glossary item to grow such as G-CSF Open a glossary item. This is within 2 weeks of having blood tests to join the trial. 
  • have already had radiotherapy to the area of skin cancer. If you have had radiotherapy to other parts of the body, all side effects must be better.
  • have had chronic lymphocytic leukaemia Open a glossary item
  • are taking an experimental drug or using a device as part of another clinical trial. This is if it is within 4 weeks of being put in a treatment group for this trial.
  • have another cancer that has been getting worse, or has needed treatment, in the past 2 years. You might be able to take part if you have had successfully treated non melanoma skin cancer Open a glossary item or a very early melanoma Open a glossary item or a very early stage cancer (in situ) apart from bladder cancer. You might be able to take part if you have early stage, low risk prostate cancer. 

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

  • have had a heart attack within 6 months being put into a treatment group 
  • have a problem with how your immune system Open a glossary item works 
  • are having treatment that damps down the immune system. This includes steroids within 7 weeks of starting trial treatments unless it was a low dose. 
  • have an autoimmune condition Open a glossary item that needs treatment apart from certain ones. Your doctor will know about this. 
  • have pneumonitis Open a glossary item or inflammation and scarring of the lungs (interstitial lung disease). Or you have had these in the past, they were not caused by infection, and you needed steroid treatment.
  • have an active hepatitis B or hepatitis C infection or any other severe infection that needs treatment
  • have hepatitis B and hepatitis C at the same time 
  • have ongoing problems from major surgery
  • have HIV that isn’t well controlled with medication or you have HIV and you have had Kaposi’s sarcoma, Multicentric Castleman’s Disease or both. Your doctor will know this.
  • have had a solid tissue or an organ transplant Open a glossary item
  • have side effects from past treatments that aren’t getting better 
  • have any other medical condition or mental health condition or there is any other reason you can’t take part 

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

  • are severely allergic to V940, pembrolizumab or anything they contain 
  • have had a live vaccination Open a glossary item within 30 days of starting trial treatment. This doesn’t apply to the seasonal flu vaccine or the approved COVID-19 vaccines as these aren’t live.
  • are pregnant or breastfeeding 

Trial design

This phase 2/3 trial is taking place worldwide. The team need 1,012 people to take part. 

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. 

There are 3 treatment groups. You have one of the following:

  • standard treatment 
  • standard treatment and pembrolizumab 
  • standard treatment, pembrolizumab and V940

Five out of every 12 people have standard treatment. Two out of every 12 people have standard treatment and pembrolizumab. And 5 out of every 12 people have standard treatment pembrolizumab and V940.

How you have trial treatment
You have pembrolizumab as a drip into a vein. V940 is an injection. You have them into a muscle in the upper arm, thigh, or buttock. 

You stop trial treatment if it isn’t working or the side effects are bad. Your doctor will talk to you about other treatment options. 

Standard treatment (group 1)
You have surgery as planned. Your doctor will tell you more about the surgery you have. You might also have radiotherapy after surgery. The team can let you know how often you have radiotherapy if this applies to you. 

Pembrolizumab and standard treatment (group 2)
In the 12 weeks before surgery, you have 2 treatments of pembrolizumab. You have it once every 6 weeks.

You then have your surgery as planned. This is about 2 weeks after your last dose of trial treatment. You may also have radiotherapy. There is a small chance you might not need to have surgery. This is only if the cancer has gone away. 

After surgery you have some scans Open a glossary item to check the cancer. You restart treatment with pembrolizumab if suitable. You have 9 more pembrolizumab treatments. 

V940, pembrolizumab and standard treatment (group 3)
In the 12 weeks before surgery you have:

  • 2 treatments of pembrolizumab. You have it once every 6 weeks.
  • 1 to 2 treatments of V940. You have it once every 3 weeks. 

You then have your surgery as planned. This is about 2 weeks after your last dose of trial treatment. You may have radiotherapy. There is a small chance you might not need to have surgery or more trial treatment. This is only if the cancer has gone away. 

After surgery you have some scans to check the cancer. You restart trial treatment if suitable. You have:

  • 9 more pembrolizumab treatments 
  • 7 to 8 more V940 treatments

There is a small chance you might not need to have surgery or more trial treatment afterwards. This is only if the cancer has gone away. 

Samples for research 
The researchers will ask people in all treatment groups if they can take a tissue sample (biopsy Open a glossary item). This is if there isn’t a previous sample that they can use when you join the trial. 

They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.

They plan to use the samples to:

  • see how well the treatment is working
  • look at genes Open a glossary item to understand more about SCC
  • look for substances called biomarkers Open a glossary item to help work out why treatment might work for some people and not for others

The team also ask to take another tissue sample if your cancer gets worse during treatment or comes back.

The team may also ask your permission to store some samples for future research. You don’t have to agree to this.

Hospital visits

You see the doctor for a physical examination Open a glossary item and have tests before you can take part. These include:

The team also ask to take photos of your skin cancer. They do this at various timepoints during the trial. It won’t be possible to identify you from the photos if you have skin cancer on your face. 

You have all your treatment at the hospital. You shouldn’t need to stay overnight. 

During treatment, you see the doctor regularly. This is for blood tests and to see how you are.

Trial scans 
For those who have pembrolizumab or V940, you have a CT scan or MRI scan:

  • 6 weeks after starting trial treatment
  • within 2 weeks of surgery 
  • 3 to 6 weeks after surgery

For those having only standard treatment, you have a scan 3 to 6 weeks after surgery.

Everyone then has a scan once every 3 months. You stop having the trial scans if your cancer gets worse.

Follow up
You see the trial doctor once or twice within a month of stopping treatment. 

If your cancer doesn’t get worse, you see the trial doctor for a check up:

  • every 3 months for 3 years
  • every 6 months for a further 2 years 

When you stop having follow up visits, a member of the trial team will call you every 3 months. This is to see how you are.

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. 

V940 is a new treatment and only a few people have had it. Having the combination of V940 with pembrolizumab is also a new combination of treatment. We don’t know what all the side effects are. 

The most common side effects of V940 we know about so far include:

There may be a small risk that you could have a serious allergic reaction to V940. This could cause a change in blood pressure, difficulty breathing or severe hives. 

The trial doctor or nurse will monitor you very closely during and after you have V940. You will have medication to treat any allergic reaction that might happen. 

Pembrolizumab can affect the immune system Open a glossary item. This may cause inflammation Open a glossary item and other reactions in different parts of the body. For many people the inflammation and reactions are not too bad. For some people they can cause serious side effects. 

These side effects could happen during treatment or months after treatment has finished. Rarely, these side effects could be life threatening. Your doctor or nurse can explain what these side effects are, the risk of them happening and what to look out for.

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 common side effects of pembrolizumab include:

  • itchy skin or skin rash 
  • diarrhoea
  • a cough
  • high temperatures
  • back, joint or tummy (abdominal) pain
  • loss of skin colour
  • not enough thyroid Open a glossary item hormone. This can cause tiredness, weight gain, feeling cold, or constipation. 
  • low levels of salt in the blood. This can cause tiredness, confusion, headache, muscle cramps, and feeling or being sick. 

We have more information about the following treatments and their side effects:

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.

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

Chief Investigator

Dr Will Ince

Supported by

Merck Sharp & Dohme Ltd

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

19948

Print page
Questions to ask your doctor about clinical trials
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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