RecruitingPHASE2, PHASE3INTERVENTIONAL

DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.

This research study, called DETERMINE, is looking at a combination of two medicines, vemurafenib and cobimetinib. These drugs are currently approved for treating a type of advanced skin cancer called melanoma in adults, especially when the cancer cells have a specific genetic change called a BRAF V600 mutation. Doctors want to find out if these same drugs could also be helpful for adults with other types of cancer that have this same BRAF V600 mutation. If the drugs work well, the study team hopes they can become available through the NHS and Cancer Drugs Fund for more patients in the future. This trial is part of a larger effort to match existing cancer drugs to rare cancers or those with particular genetic changes.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Cancer Research UK

Enrolment target

Start

01 Mar 2023

Estimated completion

01 Oct 2029

Haematological Malignancy Melanoma Thyroid Cancer, Papillary Ovarian Neoplasms Colorectal Neoplasms Laryngeal Neoplasms Carcinoma, Non-Small-Cell Lung Glioma Multiple Myeloma Erdheim-Chester Disease Thyroid Carcinoma, Anaplastic Solid Tumour

What is this study about?

This study is called DETERMINE, and it's looking into using two specific drugs, vemurafenib and cobimetinib, for certain types of cancer. These drugs are already approved for use in adults with advanced melanoma (a type of skin cancer) when the cancer has a particular genetic change called a BRAF V600 mutation. This means they've been rigorously tested and approved by health authorities like the MHRA in the UK.

Now, doctors want to see if this drug combination could treat other cancers that also have this same BRAF V600 mutation. This could include rare cancers or more common cancers where this specific gene change is unusual. If the study shows that these drugs are helpful for these other cancer types, the researchers will work with the NHS and the Cancer Drugs Fund to try and make them available to patients in the future.

This trial is just one part of a bigger DETERMINE programme. The overall goal of this programme is to find new uses for existing cancer drugs by carefully matching the right drug to patients whose cancers have specific genetic features, like the BRAF V600 mutation, or to those with rare cancer types.

Key takeaways

This study tests two existing cancer drugs for new types of cancer.
It targets adult patients whose cancers have a specific genetic change called a BRAF V600 mutation.
The goal is to find new treatment options for rare cancers or cancers with specific genetic features.
Participation involves biopsies, blood tests, taking study drugs, and follow-up for up to two years.
Potential benefits include access to new treatment, but there's no guarantee it will work for everyone.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. Your cancer needs to have a specific genetic change called a BRAF V600 mutation, which will be confirmed through special tests.

You also need to be well enough to take part, meaning your body's organs (like your liver and kidneys) are working properly, as shown by blood tests. You must also be able and willing to have a small tissue sample (a biopsy) taken and give blood samples for the study.

If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use effective birth control methods throughout 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.

Are you 18 years old or older?
Has your doctor confirmed your cancer has a BRAF V600 genetic mutation?
Are your body's main organs (like liver, kidneys) working well?
Are you able and willing to have a small tissue sample (biopsy) taken?
If you are a woman who could become pregnant, are you able to use effective birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is a 'pre-screening' where a team of experts will look at your cancer's genetic information to see if this treatment might be suitable for you. If it looks promising, you'll go through 'screening.' This involves having a new biopsy (a small tissue sample taken from your cancer) and giving blood samples for further research.

Once you begin treatment, you'll take the medicines, vemurafenib and cobimetinib. You’ll continue taking them as long as they are helping you, are not causing severe side effects, or you decide you no longer want to participate. During your treatment, you'll give blood samples regularly. After you finish taking the study drugs, you'll have follow-up checks every three months for two years to see how you're doing. The full duration of your participation will depend on how long you take the medication and the two-year follow-up period.

Potential risks and benefits

Potential benefits of joining this trial include receiving a new treatment that might help control your cancer, especially if other treatments haven't worked or if your cancer is rare. You would also be contributing valuable information that could help others with similar conditions in the future. However, there's no guarantee the treatment will work for you. Medicines always carry potential risks, including side effects, which the study team will monitor closely and explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Belfast City Hospital
Verified postcode
Belfast, United Kingdom· Recruiting
University Hospital Birmingham
Verified postcode
Birmingham, United Kingdom· Recruiting
Bristol Haematology and Oncology Centre
Verified postcode
Bristol, United Kingdom· Recruiting
Addenbrooke's Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting
Velindre Cancer Centre
Verified postcode
Cardiff, United Kingdom· Recruiting
Western General Hospital
Verified postcode
Edinburgh, United Kingdom· Recruiting
The Beatson Hospital
Verified postcode
Glasgow, United Kingdom· Recruiting
Leicester Royal Infirmary
Verified postcode
Leicester, United Kingdom· Recruiting
University College London Hospital
Verified postcode
London, United Kingdom· Recruiting
Guy's Hospital
Verified postcode
London, United Kingdom· Recruiting
The Christie Hospital
Verified postcode
Manchester, United Kingdom· Recruiting
Clatterbridge Cancer Centre
Verified postcode
Metropolitan Borough of Wirral, United Kingdom· Recruiting

Common questions

What is a BRAF V600 mutation?

It's a specific genetic change (a 'mutation') found in some cancer cells that can make them grow. This study is for cancers with this particular change.

Are these drugs new?

Vemurafenib and cobimetinib are approved for a type of skin cancer. This study is testing if they can also help treat other cancers with the same genetic change.

What happens if the drugs work?

If the study shows positive results, the researchers will work to make these drugs available to more patients through the NHS and the Cancer Drugs Fund.

Will I have to have a new biopsy?

Yes, usually you will need to have a new tissue sample (biopsy) taken to confirm your eligibility and for research purposes.

How long will I be involved in the study?

You'll take the medication as long as it's helping and not causing severe side effects, followed by check-ups every 3 months for two years after you stop treatment.

How to find out more

Aida Sarmiento Castro

determine@cancer.org.uk +44 207 242 0200 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.