Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial of SCIB1 and pembrolizumab for advanced melanoma
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
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
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.
- 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.
- have cancer that has spread to the brain
- have cancer that has spread to your eye
- have had an
immunotherapydrug 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 cancerthat has been successfully treated or early prostate cancer
- 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 drugin the past
- have an
autoimmune conditionthat 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
- 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
vaccinationin the last 4 weeks
- have a problem with drugs and alcohol
- are pregnant or breastfeeding
This is a phase 2 trial. The researchers need 25 people to take part including about 15 from the UK.
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 3 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.
You see a doctor and have some tests before you can take part. These include:
- physical examination
- eye examination
- heart trace (
- 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 (
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
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
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:
- pain, including pain in muscles, bones or joints or the tummy (abdomen)
- loss of appetite
- itchy skin or rash
- diarrhoea or constipation
- feeling sick
- shortness of breath
Your doctor will talk to you about the possible side effects before you agree to take part in the trial.
We have more information about pembrolizumab.
How to join a clinical trial
Professor Poulam Patel