CompletedInterventional

A research study to compare treatment with dabrafenib and trametinib, either taken continuously every day, or intermittently (with planned treatment breaks in each cycle), in patients with metastatic Melanoma

Melanoma is a serious type of skin cancer. In some people, the cancer cells have a specific change in a gene called BRAF. Doctors often treat this with two targeted drugs, dabrafenib and trametinib, taken as daily tablets. Usually, patients take these tablets every day without stopping. However, the cancer can become resistant to the drugs over time. This study tests whether taking planned breaks from the medication helps it work better or longer. Everyone taking part gets the same standard drugs. One group takes the tablets continuously every day. The other group takes the tablets with regular, scheduled breaks. Doctors will compare both groups to see how well the cancer responds, track side effects, and check patients' quality of life. The goal is to see if this intermittent approach is practical and safe for future care.

At a glance

Status

Completed

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

150

Start

23 Oct 2017

Estimated completion

28 Mar 2020

Melanoma

What is this study about?

Melanoma is an aggressive form of skin cancer that can spread to other parts of the body. In about half of all people with melanoma, the cancer cells carry a faulty gene called BRAF V600. This gene change acts like a broken switch, telling cancer cells to grow and divide. Fortunately, two targeted medicines called dabrafenib and trametinib can turn this switch off. Taken together as daily tablets, they can shrink tumours and keep the disease under control.

The usual approach is to take both tablets every day without stopping. While this works well at first, the cancer cells often find clever ways to work around the drugs over time. When this happens, the treatment stops working. Scientists believe that giving the body planned, regular breaks from the tablets might prevent the cancer cells from becoming resistant so quickly. Pausing treatment may also give patients relief from day-to-day side effects.

This study, called the INTERIM trial, is comparing these two approaches directly. Half of the participants take their medication every single day, while the other half follow a schedule with built-in breaks. Because both groups receive active, proven treatments, no one receives a dummy pill (placebo). The results will help doctors understand if planned breaks are practical, safe, and effective for people living with advanced melanoma.

Key takeaways

The study tests whether taking planned breaks from melanoma tablets works as well as taking them daily.
All participants receive the standard targeted drugs dabrafenib and trametinib; there is no placebo.
It is for adults with advanced melanoma that has the BRAF V600 gene change.
Researchers hope scheduled breaks might reduce side effects and delay drug resistance.
Taking part is completely voluntary and you can withdraw at any time.

Who may be eligible?

This study is open to adults aged 18 and older who have stage 3 melanoma that cannot be removed by surgery, or stage 4 melanoma that has spread to other parts of the body. Your tumour must have tested positive for the BRAF V600 gene change. To join, you should be generally well enough to carry out daily tasks, have reasonable kidney, liver, and bone marrow function, and must not have received targeted BRAF or MEK inhibitor drugs for advanced disease in the past.

You cannot join if you are currently receiving immunotherapy for your melanoma, or if you have had another active cancer within the past year. The study is also not suitable for people taking certain prescription medicines that interfere with the trial drugs, or for women who are pregnant or breastfeeding. Both men and women of childbearing age must agree to use reliable contraception 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.

I am aged 18 or over.
I have advanced melanoma (stage 3 that cannot be operated on, or stage 4).
My cancer has been confirmed to have the BRAF V600 gene mutation.
I have not previously taken BRAF or MEK targeted drugs for advanced melanoma.
I am not currently receiving immunotherapy or other experimental cancer drugs.
I am able to attend regular hospital appointments and take daily tablets.

Answer every question to see your result.

What does participation involve?

If you join the study, a computer will randomly place you into one of two groups. You will have an equal chance of being in either group. Group one takes dabrafenib and trametinib tablets every day without a break. Group two takes the same tablets on an intermittent schedule, meaning you will have planned days off medication during each cycle.

You will need to attend regular hospital visits for check-ups, blood tests, and scans (such as CT or MRI scans) to see how your tumour is responding. You will also be asked to fill out short questionnaires about your daily wellbeing and quality of life. The study team will closely monitor you for side effects. You will usually stay on the study for as long as the treatment continues to keep your cancer stable and the side effects remain manageable.

Potential risks and benefits

A potential benefit is that taking planned breaks may reduce bothersome side effects and could help keep the cancer under control for longer, although this cannot be guaranteed. However, both dabrafenib and trametinib can cause side effects such as fever, extreme tiredness, skin rashes, joint pain, nausea, and changes in blood pressure. There is also a small risk that taking breaks might allow the cancer to grow during the rest periods. Your care team will monitor you very closely throughout the trial. Taking part is entirely voluntary, and you can change your mind and leave the study at any time without it affecting your standard NHS care.

Locations (16)

Addenbrookes Hospital
City only
Cambridge, England
Churchill Hospital
Approximate
Oxford, England
The Christie Hospital
Approximate
Manchester, England
The Royal Marsden
City only
Sutton, England
Norfolk & Norwich University Hospital
Approximate
Norwich, England
Royal Preston Hospital
Unverified
Preston, England
Charing Cross Hospital
Unverified
London, England
University Hospital Birmingham (Queen Elizabeth)
Unverified
Birmingham, England
Beatson West of Scotland Cancer Centre
Unverified
Glasgow NO COUNTRY SPECIFIED, assuming England, England
Edinburgh Cancer Centre
Unverified
Edinburgh, Scotland
University College London Hospital
Unverified
London, England
Weston Park Hospital
Unverified
Sheffield, England

Common questions

Will I receive a dummy pill (placebo)?

No. Everyone in this study receives the active cancer medicines dabrafenib and trametinib. The study is only comparing whether taking them continuously or with planned breaks works better.

Can I choose which group I am in?

No. A computer allocates you to a group by chance. This random process ensures the comparison between the two treatment schedules is fair and scientifically accurate.

What happens if my cancer gets worse during the trial?

Your doctor will do regular scans. If tests show your cancer is growing or if your health changes, you will stop the trial treatment and your doctor will discuss other available therapies with you.

Are the study tablets free?

Yes. The trial medication and all tests linked directly to the study are provided at no extra cost to you through the hospital.

What if I want to stop taking part?

You are free to leave the trial at any point, for any reason. Deciding to withdraw will not change your relationship with your healthcare team or affect the quality of your NHS care.

How to find out more

Claire Mather

Official trial record

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