Active not recruitingPHASE2INTERVENTIONAL

Tebentafusp in Molecular Relapsed Disease (MRD) Melanoma

This research is focused on improving care for people who have had skin or eye melanoma removed, especially if there's a chance it might return. Researchers are exploring a new blood test to detect tiny traces of melanoma (called 'molecular relapsed disease' or MRD) early. If MRD is found, the study then investigates a drug called tebentafusp. This drug has been used in trials for more advanced melanoma. The main goal is to find out if giving tebentafusp at this earlier stage can help people with either skin (cutaneous) or eye (uveal) melanoma live longer and prevent the disease from coming back. It involves monitoring patients and, if MRD is detected, offering them the drug at specialist centres.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University of Oxford

Enrolment target

850

Start

25 Jul 2022

Estimated completion

30 Jun 2027

Melanoma (Skin)Melanoma, Uveal

What is this study about?

This study is about finding better ways to care for people who have had a type of skin cancer called melanoma, or a rare eye cancer called uveal melanoma. Specifically, it's for people whose cancer has been treated and removed, but who might still have tiny bits of cancer left that could cause it to come back. These tiny traces are what doctors call 'molecular relapsed disease' (MRD). Currently, it's a challenge to know exactly when to give further treatment in these situations.

The researchers are testing a new blood test that can spot these tiny traces of melanoma earlier than usual. If this new blood test shows that the melanoma is coming back at a very early, ‘molecular’ stage, then the study will look at giving a drug called tebentafusp. This drug has already been studied in people with more advanced melanoma, and now the researchers want to see if it can help people live longer when given earlier, based on the results of this new blood test.

The main goal is to understand if giving tebentafusp at this early point, guided by the new blood test, can stop the melanoma from growing or spreading. This could potentially help people with both skin and eye melanoma stay healthy for longer. It's an important step in trying to get ahead of the disease.

Key takeaways

This study is for people who have had skin or eye melanoma treated.
It uses a new blood test to find very early signs of melanoma returning.
If early signs are found, a drug called tebentafusp may be given.
The aim is to see if earlier treatment can help people live longer.
Participation involves regular blood tests and potential weekly infusions.
You can discuss with your doctor if this study might be right for you.

Who may be eligible?

To join this study, you would first need to have already been treated for either skin or eye melanoma. The study is for adults aged 18 and over who have a good general level of health and are expected to live for at least another three months. You would also need to have passed the new blood test, which shows that you have early signs of your melanoma returning (called molecular relapsed disease, or MRD). Importantly, scans would need to show that the melanoma hasn't visibly spread to other parts of your body.

There are also some requirements regarding other health conditions. For example, if you've had certain immune treatments before, you need to have recovered from any serious side effects. Your blood test results for general health also need to be within a healthy range. You wouldn't be able to join if you're currently taking part in other drug trials, or if you have an active infection that needs antibiotics.

Quick self-check

Have you been treated for skin (cutaneous) or eye (uveal) melanoma?
Are you 18 years old or older?
Do you feel generally well and active?
Could you have a specific genetic marker (HLA-A*0201)?
Are you able to attend regular blood tests and potentially weekly hospital visits?
Have scans shown no visible spread of your melanoma?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the first step is a pre-screening phase which lasts up to two weeks. This involves a blood test to check a specific genetic marker (called HLA-A*0201). If you have this marker, you'll then have blood tests every three months for up to two years to look for tiny traces of melanoma (MRD). If MRD is found, you'll go through further checks at one of up to ten main treatment centres in the UK to see if you can receive the study drug, tebentafusp.

If eligible for treatment, you'll receive tebentafusp weekly through a drip (IV) for up to six months. After the treatment period, you'll be followed up for another 12 months, with ongoing monitoring for both the molecular signs of melanoma and any clinical signs of the disease. In total, the study could involve monitoring for up to two years before potential treatment, and then treatment for up to six months followed by 12 months of follow-up.

Potential risks and benefits

Participating in any clinical study involves careful thought. A potential benefit of this study is that you might receive a new treatment, tebentafusp, for your melanoma at an earlier stage, which researchers hope could help you live longer. However, like all medications, tebentafusp can have side effects, and these would be fully explained to you by the study team. Being part of the study also means regular hospital visits and tests. You would have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (10)

Cambridge University Hospitals NHS Foundation Trust (Screening only)
Cambridge, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
The Clatterbridge Cancer Centre
Liverpool, United Kingdom
University College London Hospital
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Mount Vernon Cancer Centre
Middlesex, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
Churchill Hospital, Oxford University Hospitals NHS Trust
Oxford, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust (Screening only)
Sheffield, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom

Common questions

What is 'molecular relapsed disease' (MRD)?

MRD means that very tiny traces of your melanoma cancer cells can be detected in your blood, even if scans don't yet show any new tumours.

What is tebentafusp?

Tebentafusp is a drug that helps your immune system find and fight melanoma cells. It has been used in trials for more advanced melanoma.

How is tebentafusp given?

If you receive tebentafusp in this study, it will be given weekly through a drip into your bloodstream (intravenously).

Where would I receive treatment?

If you are found to have MRD and are eligible, you would receive treatment at one of a maximum of ten specialist centres in the UK.

What kind of melanoma is this study for?

This study is for people who have had either cutaneous melanoma (a type of skin cancer) or uveal melanoma (a rare type of eye cancer) that has been removed.