"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of SCIB1 injections for melanoma
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a type of immunotherapy called SCIB1 for people with melanoma.
Doctors often treat melanoma with surgery. But sometimes melanoma cannot be completely removed with surgery because it has spread to another part of the body. Or, even when it is completely removed, it can sometimes come back. Doctors are looking for new treatments to help people in this situation.
This trial is looking at a new treatment called SCIB1. It is a liquid that contains small pieces of DNA. The researchers hope that SCIB1 will activate cells in the immune system so that they attack melanoma cells.
The aims of the trial are to
- Find the highest safe dose of SCIB1
- See what effect it has on your immune system
- See what effect it has on your melanoma
The results of this study will be used to design more trials that will test how well SCIB1 works as a treatment for melanoma.
Who can enter
There are 2 parts to this trial.
You may be able to enter the 1st part of the trial or one of the groups in the 2nd part of the trial if you have melanoma that is stage 3 or stage 4 and can be measured.
You may be able to enter the other group in the 2nd part of the trial if you have had surgery to remove stage 3 or 4 melanoma in the last 12 months and still have no signs of melanoma.
And as well as the above, for both parts of the trial, you must
- Have melanoma that makes certain proteins (antigens) that your immune system can recognise, including one called HLA-A2 (the trial doctors can advise you about this)
- Have satisfactory blood test results
- Be well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Be at least 18 years old
- Be willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or partner could become pregnant
You cannot enter this trial if you
- Have cancer that has spread to your brain
- Have cancer that causes high blood levels of chemicals made by the liver
- Have had
steroidsor other cancer drugs that circulate throughout the body (systemic treatment) in the last 4 weeks
- Have had another 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 of the cervix or non melanoma skin cancer that has been successfully treated
- Have a very slow heart rate or an abnormal heart rhythm
- Have a pacemaker or other electronic medical device in your body
- Have any other medical condition that could affect you taking part in this study
- Have a skin fold measurement greater than 40mm (this is a measure of how much fat you have under the skin of your upper arm or thigh)
- Are pregnant or breastfeeding
This trial will recruit up to 54 people. Everybody taking part will have SCIB1 injections. Each time you have treatment, you have one injection into the muscle in your arm, and one into the muscle in your thigh. A doctor or nurse gives the injections using a special device. This injects the SCIB1 and then gives a short electrical impulse that lasts about half a second.
The first few people taking part in the trial will have a low dose of SCIB1. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until the researchers find the highest dose they can give safely. This first part of the trial will test 3 doses of SCIB1and is called a ‘dose escalation study’.
Once the researchers have worked out the highest safe dose from the first 3 doses tested, the people joining the 2nd part of the trial will have this dose.
At the same time as the 2nd part of the trial, another group of people with melanoma still present will have a 4th, higher dose of SCIB1 to see if it has an effect on their melanoma. Once the researchers have tested that this higher dose of SCIB1 is safe, more people with melanoma still present will also have the higher dose of SCIB1.
Everybody taking part will have 5 injections of SCIB1 over a period of nearly 6 months. If you don't have any serious side effects and the trial doctors think the treatment is helping you, they may ask you to continue having SCIB1 for longer. You may have injections every 3 to 6 months for up to 5 years.
The trial team will ask you to fill out a questionnaire after each treatment. This will ask about your experience of having this type of injection.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
- Eye tests
- Heart trace (
- Blood and urine tests
- CT scan
You will go to hospital 13 times all together during the main part of the trial. If your melanoma has not been removed by surgery you will have 2 more visits to the hospital and 3 extra CT scans. If you continue treatment after the first 6 months, you go to hospital twice and have one extra CT scan in each cycle of treatment. In this part of the study, a cycle is between 3 and 6 months.
If your melanoma has not been removed by surgery before being treated with SCIB1 and your melanoma has not got worse at the end of treatment, then you will continue to have CT scans every 3 months to see if your melanoma changes.
After you finish treatment, the trial team will contact you by phone to see how you are. They will ring you 3 times in the first year and then once a year for up to 4 more years.
If you need to have surgery to remove your melanoma during the study (including the 5 year follow period), the researchers will get a sample of the melanoma that is removed to look for any changes. They will also look at samples of your melanoma removed before you join the study, if these are available.
When you have the SCIB1 injections, you will feel a twitching in your muscle which might be painful. And your arm and leg will be sore to the touch after the treatment.
You may bleed a little after the injection and then a scab may form. The skin around the injection sites may become red and you might have bruising or swelling. The next time you have the injections, they will be on the other side of your body.
As SCIB1 is a new treatment, there may be side effects we don’t know about yet. From trials of similar treatments, we know possible side effects include
- Dizziness or fainting when you have the injections
- An immune response that can cause a loss of pigment in the skin (a condition called vitiligo) or a swelling (inflammation) of the eye that could affect your sight
- An allergic reaction causing fever or chills and flu like symptoms
- Muscle damage or infection at the injection site
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.
Professor Poulam Patel
Experimental Cancer Medicine Centre (ECMC)