A trial of SCIB1 and immunotherapy for advanced melanoma (The Scope Study)

Cancer type:

Melanoma

Secondary cancers

Status:

Open

Phase:

Phase 2

This trial is looking at adding SCIB1 to pembrolizumab or nivolumab and ipilimumab 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

Immunotherapy is a usual treatment for advanced melanoma. You might have pembrolizumab or nivolumab in combination with ipilimumab. These are types of immunotherapy. But these treatments don'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 immunotherapy 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 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
have HIV, an active hepatitis B or hepatitis C infection or any other severe infection that needs treatment
have any other medical condition that could affect you taking part in this trial

Other
You:

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 87 people to take part.

You have:

SCIB1 and
pembrolizumab or nivolumab and ipilimumab

Your doctor decides whether you should have pembrolizumab or nivolumab and ipilimumab. They will discuss this with you.

You have 10 SCIB1 treatments as follows:

5 treatments within a 6 month period
then every 3 months

You have 4 SCIB1 injections which you have into different areas of your upper arm or the muscle in your thigh. 4 injections are 1 treatment of SCIB1.

A doctor or nurse gives the injections using a special needle free device. The SCIB1 enters the skin at high pressure and reaches the muscle. The team can tell you more about this.

You have pembrolizumab every 6 weeks or nivolumab and ipilimumab every 4 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.

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
3 months
4½ months
6 months and then
every 3 months after that

Side effects

Having SCIB1 and pembrolizumab or nivolumab and ipilimumab is a new treatment. So, there may be some side effects we don’t know about yet.

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.

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

Pembrolizumab, nivolumab and ipilimumab can affect the immune system. They 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.

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 most common side effects of pembrolizumab and nivolumab and ipilimumab are: