
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
This study is looking at a type of called tebentafusp. It is for people with melanoma of the skin (cutaneous), or of the eye (uveal), that:
Surgery is the main treatment for melanoma. You might also have other treatments if you are at an increased risk of your cancer coming back or if your cancer has spread. Possible treatments include:
You may have treatment with if you have melanoma of the eye (uveal melanoma).
These treatments can work well, but some people have a small number of cancer cells left at the end of treatment. This is called molecular relapsed disease (MRD). Doctors can find the cancer cells in a blood test. But they cannot see the cancer on a scan at that time.
Researchers would like to improve treatment for people with melanoma that have an increased risk of it coming back. They think giving a new treatment early, when they find MRD, might help people in this situation.
Tebentafusp is a type of . It is made from two different proteins that are joined together. One of the proteins recognises and attaches to a protein called gp100. There are high levels of gp100 in some melanoma cells.
The other protein recognises and attaches to a protein called CD3. CD3 is on certain cells of the body’s immune system. By sticking to gp100 and CD3, tebentafusp activates your to recognise and destroy cancer cells.
To work, your immune system needs to recognise the tebentafusp. This is only possible for people with a called HLA-A*0201. Around 50 in 100 people (around 50%) have this HLA protein on most of their cells.
We know from research that tebentafusp has helped people with melanoma that has spread (advanced melanoma). Now, doctors would like to find out if it could help people at an earlier stage. This trial is looking into this.
This study is in 3 parts. The 1st part, called pre screening, is to find people with HLA-A*0201.
The 2nd part is called molecular screening. It is for people with HLA-A*0201. You have blood tests to see if you have MRD.
The 3rd part of the study is the main study. It is for people with HLA-A*0201 and MRD. Everyone joining the 3rd part of this study will have tebentafusp.
The main aims of the trial are to find out:
The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You must have melanoma of the skin (cutaneous), or melanoma of the eye (uveal).
Who can take part – Pre screening
You may be able to join the 1st part of this study, called pre-screening, if:
Who can take part – Molecular screening
You may be able to join the 2nd part of this study, called molecular screening if:
As well as the above, one of the following must apply:
Who can take part – Main study
You may be able to join the 3rd part of the study (main study) if all of the following apply. You:
Who can’t take part in the main study
Cancer related
You cannot join the main study if any of these apply. You:
Medical conditions
You cannot join the main study if any of these apply. You:
Other
You cannot join the main study if any of these apply. You:
This is a phase 2 study. Researchers hope that around 850 people from the UK will agree to take part in the pre screening part of the study. They think that around 350 to 380 people will take part in the molecular screening part of the study. And the team think that around 50 people will have tebentafusp in the main study.
If you are not found to have MRD at any of your molecular screening visits you are not able to join the main study. This is because the trial team think that tebentafusp will not be able to help you.
The amount of tebentafusp increases each time you have the drug for the first month. This is to make sure the side effects are not too bad.
You have tebentafusp for up to 6 months as long as:
The study team use your blood tests from molecular screening to look at changes in the DNA. This might help doctors predict which patients will benefit from treatment in the future.
The study team will ask if you are happy for blood samples to be used in future research. This is because genetic research is changing all the time. You don’t have to give these samples if you don’t want to. You can still take part in the trial.
Pre screening
You go to the hospital to have a blood test. You might not need to if there is a recent sample available for the team or if your HLA status is already known.
Molecular screening
There will be up to 5 hospital visits in total.
You see the study team and have some tests first of all. The tests include:
You also have a liver MRI scan if you have uveal melanoma.
You might go to the hospital more than once to complete these tests.
During molecular screening you go to the hospital about every 3 months for a physical examination and blood test. You have these blood tests for up to a year.
Main study
You are likely to go to one of up to 10 specialist hospitals for the main study. This might mean you have to go to a different hospital from where you took part in molecular screening.
You see the study team and have some tests before you start treatment. These include:
You might also have a liver MRI scan if you have melanoma of the eye (uveal melanoma).
You might go to the hospital more than once to complete these tests.
You go to the hospital once a week to have tebentafusp. You might have up to 6 months of treatment, which would be 24 hospital visits. The drip takes around 15 to 20 minutes. You stay in hospital overnight the first 3 times you have tebentafusp. This is so your healthcare team can see how you are feeling after the drug.
You usually have the rest of the doses in the outpatient department of the hospital. You are monitored between 30 minutes and 4 hours after each dose. How long you stay for monitoring depends on any side effects.
At each visit for tebentafusp you have some tests, these include:
You may also have a heart trace (ECG). After the first 3 doses of tebentafusp you have an ECG only if your doctor thinks this is needed.
Around 28 days after your last dose of tebentafusp you go to the hospital for a follow up visit. The team see how you are getting on. You have some of the same tests you had during your treatment visits.
Follow up
You see the study team every 3 months for a year. This is called follow up. You have research blood tests and see the team to talk about how you have been feeling.
The study 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.
Tebentafusp can affect the These side effects could happen during treatment or 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. |
You have regular blood tests to check the levels of different substances in the blood.
We have more information about:
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Mark Middleton
University of Oxford
Immunocore
Cancer Research UK Oxford Centre
NIHR Oxford Biomedical Research Centre
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.