A trial of SCIB1 and iSCIB1+ with immunotherapy for advanced melanoma (The Scope Study)
Cancer type:
Status:
Phase:
This trial is looking at adding SCIB1 or iSCIB1+ to nivolumab and ipilimumab for melanoma. It is also 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
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 
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 treatments called SCIB1 and iSCIB1+.
SCIB1 and iSCIB1+ are cancer vaccines. They are liquids that contains small pieces of 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. iSCIB1+ is similar to SCIB1. Researchers think it might help more people with melanoma.
The main aims of this trial are to:
- see if SCIB1 or iSCIB1+ 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 (for SCIB1)
- are suitable to have pembrolizumab or nivolumab in combination with ipilimumab
- 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 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 130 people to take part.
You have:
- SCIB1 or iSCIB+ 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 11 SCIB1 or iSCIB+ treatments as follows:
- 6 treatments within a 6 month period and then
- every 3 months
You have 4 SCIB1 or iSCIB+ injections into different areas of your upper arm or the muscle in your thigh. 4 injections are 1 treatment of SCIB1 or iSCIB+.
A doctor or nurse gives the injections using a special needle free device. The SCIB1 or iSCIB+ 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 () 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 is a new treatmnt. SCIB1 or iSCIB+ with nivolumab and ipilimumab is also 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
iSCIB1 has not been tested in people yet. So researchers don't know what the side effects are. They think they might be similar to the side effects of SC1B1.
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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. |
The most common side effects of pembrolizumab and nivolumab and ipilimumab are:
- tiredness
- pain, including pain in muscles, bones or joints or the tummy (abdomen)
- loss of appetite
- itchy skin or rash
- diarrhoea or constipation
- feeling sick
- fever
- cough
- 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:
Location
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
Professor Poulam Patel
Supported by
Scancell Ltd
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
