A trial of SCIB1 and pembrolizumab for advanced melanoma

Cancer type:

Melanoma

Secondary cancers

Status:

Open

Phase:

Phase 2

This trial is looking at adding SCIB1 to pembrolizumab for melanoma.

It is for people whose melanoma has grown into surrounding tissues or spread elsewhere in the body. This is advanced melanoma.

More about this trial

Pembrolizumab is a usual treatment for advanced melanoma. It is an immunotherapy. But it doesn’t work for some people. Doctors think this is because their immune system Open a glossary item isn’t working well enough to attack the cancer cells.

Researchers are looking for ways to improve treatment. In this trial, they are looking at a new treatment called SCIB1.

SCIB1 is a cancer vaccine. It is a liquid that contains small pieces of DNA Open a glossary item from cancer cells. We know from previous research that SCIB1 might help activate cells in the immune system. This may help the cells of the immune system to recognise and destroy melanoma cells.

The main aims of this trial are to:

see if SCIB1 improves treatment results
see if it increases the length of time that pembrolizumab works
learn more about side effects of combined treatment

Who can enter

The following bullet points list 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 melanoma that has grown into surrounding tissues or spread elsewhere in the body (stage 3 or stage 4 melanoma)
have an area of melanoma that can’t be removed with surgery
haven’t had treatment for advanced cancer unless it was treatment after surgery and you had the last dose at least 4 weeks ago
have melanoma that makes certain proteins that your immune system can recognise
are suitable to have pembrolizumab
have had a test to see if you have changes in the BRAF gene and doctors know your BRAF status
have at least one area of melanoma that doctors can measure on a scan
had a tumour sample taken that the trial team can test
have satisfactory blood test results
are well enough to carry out your normal activities, apart from heavy physical work (performance status 0 or 1)
are willing to use reliable contraception during the trial and for 4 months afterwards 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 trial if any of these apply.

Cancer related
You:

have cancer that has spread to the brain
have cancer that has spread to your eye
have had an immunotherapy drug such as pembrolizumab, nivolumab or ipilimumab in the past unless you had it shortly after surgery
might need another type of anti-cancer treatment while taking part in the trial
have had steroids in the week before starting treatment or another treatment that dampens the immune system in the last week apart from inhalers, creams or steroids to replace hormones
have had an experimental drug as part of a clinical trial in the last 4 weeks
have had any other type of cancer in the last 5 years apart from carcinoma in situ (CIS ) of the breast or cervix, non melanoma skin cancer that has been successfully treated or early prostate cancer

Medical conditions
You:

have a pacemaker or other electronic medical device in your body
have severe heart disease or heart problems such as a heart attack in the last 6 months, a very slow heart rate or an abnormal heart rhythm
have had a severe hypersensitivity reaction to a monoclonal antibody drug in the past
have an autoimmune condition that needs treatment apart from vitiligo or childhood asthma that has got better, thyroid problems that are controlled by medications, use of an inhaler or have steroid injections into a joint
have HIV
have hepatitis B or hepatitis C
have any other medical condition that could affect you taking part in this trial

Other
You:

have a skin fold measurement greater than 50 mm (this is a measure of how much fat you have under the skin of your upper arm or thigh)
have had a vaccination in the last 4 weeks
have a problem with drugs and alcohol
are pregnant or breastfeeding

Trial design

This is a phase 2 trial. The researchers need 44 people to take part..

You have:

SCIB1
pembrolizumab

You have SCIB1 as follows:

5 treatments within a 6 month period
then every 3 months

You have 2 SCIB1 injections which you have into different areas of your upper arm or the muscle in your thigh. 2 injections are 1 treatment of SCIB1.

A doctor or nurse gives the injections using a special handheld device. This injects the SCIB1 and then gives a short electrical impulse that lasts less than half a second.

You have pembrolizumab every 6 weeks. You have it as a drip into a vein.

You have treatment for up to 2 years as long as it is working and the side effects aren’t too bad.

The trial team ask you to fill out a questionnaire after each injection of SCIB1. This asks about your experience of having this type of injection.

Hospital visits

You see a doctor and have some tests before you can take part. These include:

physical examination
eye examination
heart trace (ECG )
urine tests
blood tests
CT scan

You also have a test to see if you have melanoma that makes certain proteins that your immune system can recognise. The trial team test a sample of tissue (biopsy Open a glossary item ) you gave when you were first diagnosed.

You see the trial team for a check up 1 month after you finish treatment. If you do not have a regular visits to your doctor, a member of the trial team will call you every 3 months for up to a year to see how you are getting on.

You have a CT scan:

at the start of the trial
4½ months later
6 months later
every 3 months after that

Side effects

Having SCIB1 and pembrolizumab at the same time is a new treatment. So, there may be some side effects we don’t know about yet. The trial team will monitor you during the time you have treatment and you have a phone number to call if you are worried about anything.

Only a few people have had SCIB1. The possible side effects include:

bruising, redness and tenderness at the site of the injection
tiredness (fatigue)
blurred vision
headache

When you have the injections, you will feel twitching in your muscle, which might feel painful. Your arm and leg will be sore to the touch afterwards.

Pembrolizumab 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.

If you have any of these side effects, you should tell the doctor or nurse as soon as possible. You should tell them that you are on or have been on an immunotherapy.

The most common side effects of pembrolizumab are: