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 Open a glossary item 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 Open a glossary item) of the breast or cervix, non melanoma skin cancer Open a glossary item 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  Open a glossary itemin the past
  • have an autoimmune condition  Open a glossary itemthat 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 Open a glossary item 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 Open a glossary item)
  • 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:

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

Cardiff
Northwood
Nottingham
Oxford
Sheffield
Taunton

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Poulam Patel

Supported by

Scancell Ltd

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16281

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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