Adjuvant Tebentafusp in High Risk Ocular Melanoma
This study focuses on uveal melanoma, a type of eye cancer. After initial treatment, this cancer often returns. Doctors want to find ways to prevent this, especially for people with a high risk of recurrence. This trial is investigating a medicine called tebentafusp. This drug has already shown promise in treating people when the cancer has spread. Researchers now want to see if giving tebentafusp early, after the first treatment, can reduce the chance of the cancer coming back. The study is for adults who have had their primary uveal melanoma treated and are considered high risk, meaning the cancer is more likely to return.
At a glance
What is this study about?
When someone is diagnosed with uveal melanoma, a type of eye cancer, they usually have treatment to remove or destroy the main tumour. However, for many people, especially those whose cancer is considered high-risk, there's always a worry that the cancer might come back or spread to other parts of the body. Currently, after the initial treatment, doctors mainly watch and wait to see if the cancer returns. This can be a very anxious time.
This study is looking into a new approach. Researchers are investigating a medicine called tebentafusp. This medicine has already shown good results in people whose uveal melanoma has spread to other parts of the body. Now, the question is: can it help prevent the cancer from coming back in the first place? By giving tebentafusp to high-risk patients soon after their initial treatment, the researchers hope to reduce the chances of the cancer returning and improve their long-term health.
This clinical trial is an important step in finding better ways to manage uveal melanoma. If tebentafusp proves effective at preventing recurrence, it could significantly change how doctors care for people with this type of cancer in the future, offering a new treatment option where currently there isn't one. The study will help determine if this new strategy can give patients peace of mind and better outcomes.
Key takeaways
- This study is for people with high-risk uveal melanoma.
- It aims to prevent the cancer from returning after initial treatment.
- The new medicine being tested is called tebentafusp.
- Tebentafusp has already helped people with advanced uveal melanoma.
- Participation involves regular hospital visits, tests, and taking the study medication.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study,您 must first have been diagnosed with uveal melanoma, a type of eye cancer (but not iris melanoma). You should have already had your primary cancer treated, either with surgery or radiotherapy, and this treatment must have finished no more than 11-12 weeks before joining the study.
It's very important that your cancer is considered 'high-risk,' meaning there's a higher chance it might come back. Your doctor will be able to tell you if you meet these criteria based on specific details about your cancer. You must also be generally well, able to perform your usual daily activities, and be 18 years old or older. You'll also need to have a specific genetic marker (HLA-A*02:01) in your blood, which your local doctor can check.
There are also some reasons why you might not be able to join. For example, if you have certain heart conditions or other significant health problems that could make the treatment unsafe. You must not show any signs that your cancer has already come back or spread to other parts of your body. Women who could become pregnant will need to use effective birth control during and for some time after the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Have you been diagnosed with uveal melanoma (not iris melanoma)?
- Was your primary eye cancer treated within the last 11-12 weeks?
- Has your doctor told you that your cancer is considered 'high-risk'?
- Are you 18 years old or older?
- Are you generally well and able to do your daily activities?
- Do you have no signs that your cancer has returned or spread yet?
What does participation involve?
If you join this study, you will receive doses of the study medication, tebentafusp. The frequency and duration of these doses will be determined by the study plan. You'll have regular appointments at the hospital or clinic at set times to check how you're doing, monitor for any side effects, and make sure the treatment is working as expected. These visits will likely include blood tests, physical examinations, and possibly imaging scans (like MRI or CT scans) to check for any signs of the cancer returning and to monitor your overall health.
During the study, you'll be watched closely by the medical team. There will also be a follow-up period after you finish taking the study drug, where you'll continue to have check-ups to track your long-term health and any late effects. The total duration of your involvement, from starting the treatment to the final follow-up, will be explained in detail by the study team. You'll receive all your study medication and related medical care at no cost.
Potential risks and benefits
Locations (14)
- Cliniques Universitaires Saint-LucVerified postcodeBrussels, Belgium· Recruiting
- Centre Antoine LacassagneVerified postcodeNice, France· Recruiting
- Institut Curie - Hôpital de ParisVerified postcodeParis, France· Recruiting
- Charite - Universitaetsmedizin Berlin - Campus Benjamin FranklinVerified postcodeBerlin, Germany· Recruiting
- Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer CenterVerified postcodeHamburg, Germany· Recruiting
- Universitaetsklinikum Heidelberg - Frauenklinik / HautklinikVerified postcodeHeidelberg, Germany· Recruiting
- Leiden University Medical CentreVerified postcodeLeiden, Netherlands· Recruiting
- Erasmus MCVerified postcodeRotterdam, Netherlands· Recruiting
- Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of OncologyVerified postcodeWarsaw, Poland· Recruiting
- Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia)Verified postcodeL'Hospitalet de Llobregat, Spain· Recruiting
- Hospital Clinico Universitario De ValladolidVerified postcodeValladolid, Spain· Recruiting
- Sahlgrenska UniversitetssjukhusetVerified postcodeGothenburg, Sweden· Recruiting
Common questions
What is uveal melanoma?
Uveal melanoma is a rare type of cancer that affects the eye. It starts in the uvea, the middle layer of the eye wall.
What does 'high-risk' mean in this study?
High-risk means that based on specific features of your cancer, such as its size or certain genetic changes, there's a higher chance it might come back or spread after initial treatment.
What is tebentafusp?
Tebentafusp is a new type of medicine that helps your immune system find and fight cancer cells. It's already been shown to help people with advanced uveal melanoma.
Will I receive tebentafusp if I join?
In this type of study, participants are usually randomly assigned to either receive the new drug (tebentafusp) or the standard approach (observation). Your study doctor will explain this in more detail.
Does this study involve surgery?
No, this study is for people who have already completed their primary treatment for uveal melanoma, which typically involves surgery or radiotherapy, and are looking at ways to prevent the cancer from returning.
How to find out more
EORTC HQ
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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