DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers.
This study, called DETERMINE Treatment Arm 07, is testing two existing cancer drugs, dabrafenib and trametinib. These drugs are already used for certain skin and lung cancers, and also some brain tumours in children. They work particularly well for cancers that have a specific gene alteration known as BRAF V600. Researchers now want to find out if these same drugs could be helpful for people with other types of cancer that also have this genetic change, especially rare cancers. The main goal is to see if these treatments can be made available through the NHS and Cancer Drugs Fund if they prove to be effective. The study includes adults, children, and young adults.
At a glance
What is this study about?
Imagine your body's cells are like building blocks, and sometimes a small change or 'fault' in one of these blocks, called a gene, can make cells grow out of control, leading to cancer. This study is looking at whether two specific medicines, dabrafenib and trametinib, can help treat various cancers that have a particular gene fault called 'BRAF V600'.
These two medicines are already approved and used in the UK for some cancers, like certain types of skin and lung cancer, and a brain tumour in children, as they've been proven to work well for these specific conditions. However, many other types of cancer can also have this same 'BRAF V600' gene fault. The doctors and researchers running this study want to see if these medicines could also be effective for people with these other cancers, particularly those that are rare. If the results are good, the aim is to work with the NHS to make these treatments more widely available.
This study is part of a larger research programme called DETERMINE, which aims to match existing cancer drugs to cancers that have specific characteristics, like a particular gene fault. This way, treatments can be more targeted and potentially more effective for a wider range of patients.
Key takeaways
- Tests new uses for existing cancer drugs.
- Focuses on cancers with a specific gene change (BRAF V600).
- Includes adults, children, and young adults.
- Aims to make effective treatments more widely available on the NHS.
- Involves regular monitoring and follow-up.
Who may be eligible?
To be considered for this study, you would need to have a confirmed cancer diagnosis that has a specific gene change called 'BRAF V600'. This gene change must be found using a reliable, modern testing method. You would also need to be at least one year old and weigh at least 8 kilograms.
There are also some important rules around pregnancy and breastfeeding. If you are a woman who could become pregnant, you'd need to have a negative pregnancy test before starting the study drugs and agree to use a specific type of non-hormonal birth control throughout the study and for a period after. This is because the study drugs can affect hormonal contraception. If you are breastfeeding, you would need to stop once treatment begins and for some time after.
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.
- Do you have a cancer diagnosis?
- Has your cancer been tested for the 'BRAF V600' gene change, and was it found?
- Are you at least 1 year old and weigh at least 8 kilograms?
- If you are a woman who could become pregnant, are you able to use specific non-hormonal birth control?
- If you are breastfeeding, are you willing to stop during the study and for a period after?
What does participation involve?
If you decide to take part, your doctor will first assess whether the study medicines are right for you, based on special genetic tests of your cancer. If you agree, you’ll have a biopsy and blood tests taken for research purposes. You will then start taking the study medicines, dabrafenib and trametinib. You'll continue taking these medicines for as long as they are helping you and not causing too many side effects, or until you decide you no longer want to participate.
Throughout your treatment, you will need to give blood samples regularly. After you stop taking the medicines, whether it’s because your cancer has progressed, side effects are too much, or you've decided to stop, you will have follow-up visits every three months for two years. This is to see how you are doing after the treatment.
Potential risks and benefits
Locations (27)
- Belfast City HospitalVerified postcodeBelfast, United Kingdom
- University Hospital BirminghamVerified postcodeBirmingham, United Kingdom
- Birmingham Children's HospitalVerified postcodeBirmingham, United Kingdom
- Bristol Royal Hospital for ChildrenVerified postcodeBristol, United Kingdom
- Bristol Haematology and Oncology CentreVerified postcodeBristol, United Kingdom
- Addenbrooke's HospitalVerified postcodeCambridge, United Kingdom
- Velindre Cancer CentreVerified postcodeCardiff, United Kingdom
- Cardiff Children's HospitalVerified postcodeCardiff, United Kingdom
- Western General HospitalVerified postcodeEdinburgh, United Kingdom
- The Beatson HospitalVerified postcodeGlasgow, United Kingdom
- Royal Hospital for Children GlasgowVerified postcodeGlasgow, United Kingdom
- Leicester Royal InfirmaryVerified postcodeLeicester, United Kingdom
Common questions
What is a 'BRAF V600 mutation'?
It's a specific change in a gene in your cancer cells that can make them grow faster. These drugs are designed to target this change.
Are dabrafenib and trametinib new drugs?
No, they are already approved drugs for certain cancers, but this study is testing if they can help people with other types of cancer that have the same gene change.
Who can take part in this study?
Adults, children (over 1 year old and weighing at least 8kg), and young adults with various cancers that have the 'BRAF V600' gene change can be considered.
What happens if the drugs work for my cancer?
If the study shows good results, the researchers will work with the NHS to try and make these drugs available more widely for patients with these specific cancers.
Will I need regular check-ups if I join?
Yes, you will have regular visits and blood tests during treatment, and then follow-up appointments every three months for two years after you stop the study drugs.
How to find out more
Aida Sarmiento Castro
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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