A study looking at V940 immunotherapy with pembrolizumab for people with high risk melanoma (INTerpath-001)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is looking at an
It’s for people who have:
- had all their melanoma removed with surgery and
- not had any other cancer treatment for their melanoma
More about this trial
Often the first type of treatment for melanoma skin cancer is surgery.
Depending on how big the cancer is, and if it has spread, treatments after surgery can include:
- immunotherapy
targeted cancer drugs
Treatment can work well, but some people with stage 2,3 or 4 melanoma have a higher risk of their cancer coming back after surgery. Doctors would like to improve treatment for people in this situation.
Pembrolizumab is a type of immunotherapy. It stimulates the body's
Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called
Some people with melanoma already have pembrolizumab after surgery or if their cancer has spread.
V940 is a type of personalised immunotherapy. It’s a new drug. It is also called mRNA-4157. Scientists make each treatment individually for everyone taking part. It uses the
Scientists make each V940 treatment for each person taking part using:
- a tissue sample from their melanoma
- a blood test they have before they take part
In this study, researchers are looking at pembrolizumab and V940 to see if they work well together.
The main aims of this study are to find out:
- more about the safety of V940 with pembrolizumab when compared to pembrolizumab and a dummy drug (
placebo ) - how well V940 with pembrolizumab works when compared to pembrolizumab with a dummy drug
- more about the side effects of treatment
- about the
quality of life of the people taking part
Who can enter
The following bullet points are a summary of 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 melanoma skin cancer that is at least 2mm thick and the skin covering the cancer may, or may not, be broken (ulcerated). The cancer may have spread to the nearby
lymph nodes or to another area of the body. This is stage 2b to stage 4 melanoma. You may be able to take part if your melanoma has come back (recurred) after you’ve had it removed. This is as long as you have had surgery again. Your doctor can explain more. - have a good quality tissue sample from a recent surgery available for the study team to look at. There must be enough of the sample so that the trial team can do some tests on it called next generation sequencing. Your doctor can tell you more.
- have not had any treatment that reaches the whole body for melanoma (systemic treatment). You might be able to take part if you have had
radiotherapy to where the cancer started (primary site ) or after surgery to remove one or more lymph nodes. To take part your radiotherapy must have finished by 11 weeks after surgery and 2 weeks before you have your first dose of the study drug. - have had your surgery to remove the melanoma at the most 13 weeks before having your first dose of pembrolizumab in this study. And there is now no sign of your melanoma.
- have no signs of melanoma either on a scan or when your doctor examines you within 28 days before
randomisation - have had a
biopsy of any part of your skin that looked like it could be melanoma. Other than the melanoma you are having treatment for, the test results must show that it was not cancer. - are fit and active but might not be able to do heavy physical work (performance status 0 or 1) and this hasn’t changed within the 7 days before your first dose of pembrolizumab in the study
- are willing to use reliable contraception during the study and for at least 4 months after your last dose of treatment if there is any chance you could become pregnant
- are willing to avoid breastfeeding during the study and for at least 4 months after your last dose of treatment
- have satisfactory blood test results and tissue sample quality results. Your doctor can tell you more.
- are at least 18 years old
Who can’t take part
Cancer related
You cannot join this study if any of these apply. You:
- have melanoma of the eye (ocular melanoma) or melanoma of the layer of tissue that covers the inside surface of certain parts of the body (mucosal melanoma)
- have had certain
checkpoint inhibitors before. Your doctor will know which drugs these are. - have had any cancer treatment that reaches your whole body (systemic anti cancer therapy or SACT) before
randomisation - have cancer cells that have spread further than 2cm from the
primary tumour but before the nearest lymph node (in-transit metastases). And they are not able to be removed with surgery. - have side effects of radiotherapy that are causing you problems
- you are having treatment with steroids long term, this is apart from small doses. Or you are having any other treatment that dampens down your
immune system within the 7 days before your first dose of study treatment. - have another cancer that has been getting worse, or has needed treatment, in the past 3 years. You might be able to take part if you have had
basal cell skin cancer ,squamous cell skin cancer 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. You might be able to take part if you have had another primary melanoma. - have had melanoma that has spread to the
central nervous system or the thin layer between the brain and the spinal cord - have had treatment with a cancer vaccine before
- have had a red blood cell transfusion,
platelet transfusion or any colony stimulating factors such asG-CSF in the 2 weeks before having blood tests to see if you’re able to take part in the study
Medical conditions
You cannot join this study if any of these apply. You:
- have a wound that is not healing well
- have had heart failure within the last 6 months unless it is well controlled. Your doctor will know more.
- have got an immunodeficiency disorder
- have an active
autoimmune disease that has needed treatment in the last 2 years apart from certain ones. Your doctor can explain more. - have active hepatitis B or hepatitis C
- have HIV unless it is well controlled on antiretroviral medication. Your doctor can explain more.
- have
pneumonitis 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 any other serious physical or mental health condition, or social circumstances, that could prevent you from taking part
- have had a solid tissue or
organ transplant - have had major surgery and have not recovered fully. Or you are still having side effects from surgery.
Other
You cannot join this study if any of these apply. You:
- are allergic to V940 or pembrolizumab or anything they contain
- have had a
live vaccine in the 30 days before your first dose of study drug. You can have a COVID-19 or flu vaccine at certain times while taking part in this study. - have had another study medication within 4 weeks of having the first dose of study drug
- are pregnant or breastfeeding
Trial design
This is a phase 3 study. The researchers need around 1,089 people to take part.
It is a randomised double blind study. 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 you or your doctor know which treatment you have. During the study your doctor will be able to find out what treatment you are having, if necessary. There are 2 treatment groups:
- Group 1 - pembrolizumab and V940
- Group 2 - pembrolizumab and a dummy drug (placebo)
Out of every 3 people taking part:
- 2 people will be in group 1 and will have pembrolizumab and V940
- 1 person will be in group 2 and will have pembrolizumab and a dummy drug
You have pembrolizumab as a drip into a vein. You have it every 6 weeks. This is a
You have up to 9 cycles of pembrolizumab, as long as it is working, and the side effects are not too bad.
You have V940, or the dummy drug, as an injection into the muscle. You have V940, or the dummy drug, once every 3 weeks. You have up to 9 doses, as long as it is working, and the side effects are not too bad.
Treatment on the study can take up to about a year.
Blood samples for research
The team take extra blood samples during the study. Where possible they take these when you have your routine bloods done.
Researchers use these samples for:
genetic testingbiomarker testing
The researchers want to use the results to learn more about melanoma and:
- how the study drugs work in the body
- why treatment works better for some people than for others
- any link between your
HLA proteins and the study treatment or melanoma
Tissue samples for research
As well as to make your treatment, the study team may use your tissue sample to improve and develop tests to help people with cancer. The study team can give you more information.
The study team ask for another
Quality of life
You fill in questionnaires on an electronic tablet at certain points during the study. This is to find out about your daily life and how you are feeling. This is to find out more about your quality of life.
Hospital visits
You see the doctor to have tests before taking part. These tests include:
- a
physical examination - a scan, such as a CT scan, of the chest, tummy (abdomen) and
pelvis - a brain
scan - heart trace (
ECG ) - blood tests
- urine test
- pregnancy test – if there is any chance you could become pregnant
You might have a bone scan if needed.
This might be slightly different if the team ask you to think about joining the study before surgery. The study team will explain this to you in more detail. It’s called limited screening. You then sign the main
You have your treatment as an outpatient in hospital. You also have some tests and scans at certain visits. Your team will let you know your schedule. Tests include:
- scans, such as an MRI scan or CT scan
- a heart trace (ECG)
- blood tests
- urine test
- having a picture taken of any new melanomas that develop while you’re taking part – the team try and make sure you can’t be recognised from the picture if it is on your face
If your cancer comes back
You stop having treatment on the study if your melanoma comes back. Your team will discuss the next treatment options with you. You go back to the hospital up to 30 days after you stop having study treatment for a check up and blood tests. You may also have other tests at this visit.
Follow up
After treatment, the team monitor your progress for up to another 6 years. This is called follow up.
You see the study team for a check up and tests around 30 days after having the last dose of study treatment then:
- around every 3 months for year 1 and 2
- around every 6 months for year 3 and 4
- once in year 5
You may continue to visit the hospital after the first 5 years. The study team will let you know your follow up schedule. The tests you have at treatment visits are similar to the ones you had before and during treatment.
After 5 years, the study team get in touch with you around once every 3 months to see how you are getting on.
Side effects
The study 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 drug. Because of this there might be side effects we don’t know about yet.
Possible side effects of V940 include:
- pain, redness and swelling at the injection site
- swollen
lymph nodes - changes in white blood cell levels
- fever
- extreme tiredness (fatigue)
- flu-like symptoms
- headache
- pain, such as muscle or joint pain
- feeling sick
- reduced appetite
- diarrhoea
Pembrolizumab can affect the 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. |
The most common side effects of pembrolizumab are:
- skin changes such as skin rash, itchy skin or loss of skin colour
- diarrhoea
- cough
- joint pain
- fever
- back pain
- tummy (abdominal pain)
- low levels of
thyroid hormones. You may feel tired, feel cold or gain weight. - low levels of salt in the blood. You may feel tired, confused, or sick. You might also have a headache or muscle cramps.
We have more information about pembrolizumab including possible 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.
Chief Investigator
Dr Heather Shaw
Supported by
Merck, Sharp and Dohme UK
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040