Active not recruitingPHASE3INTERVENTIONAL

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

This study is for people who have had a type of skin cancer called melanoma, specifically Stage IIB or IIC, which has a particular gene change (BRAF V600E/K mutation). After surgery, some people in the study will receive a combination of two medications, encorafenib and binimetinib, for 12 months. Others will receive inactive dummy pills (placebos). The main goal is to find out if these drugs can help prevent the melanoma from returning, compared to just regular check-ups. It's a large, international study where neither the patients, doctors, nor researchers will know who is getting the active drugs until the end, to make the results as fair and accurate as possible.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Pierre Fabre Medicament

Enrolment target

815

Start

02 May 2022

Estimated completion

02 May 2035

Melanoma

What is this study about?

This study, called Columbus-AD, is designed to see if a combination of two drugs, encorafenib and binimetinib, can help people with a specific type of skin cancer called melanoma. This is for individuals who have already had surgery to remove their melanoma, and their cancer has a particular genetic feature called a BRAF V600E/K mutation. Even though the cancer has been removed, there's a risk it might come back.

The main idea of the study is to compare what happens when people take these two drugs for 12 months after surgery, versus what happens with standard care, which usually involves regular check-ups to monitor for any return of the cancer. The researchers want to know if these drugs can effectively reduce the chance of the melanoma coming back. This is considered a 'Phase 3' study, which means it's a large trial that aims to confirm if a new treatment is better than existing ones and is safe enough for wider use.

To make sure the study results are reliable, it's set up so that neither the patients, the doctors, nor the researchers will know who is receiving the active drugs and who is getting inactive dummy pills (placebos). This is known as a 'triple-blind' study. Everyone will be monitored closely, and follow-up will continue for up to 10 years to understand the long-term effects of the treatment.

Key takeaways

This study is testing two drugs (encorafenib and binimetinib) to prevent melanoma from returning after surgery.
It's for people with Stage IIB/C melanoma that has a specific BRAF gene mutation.
You would either receive the drugs or dummy pills (placebo) for 12 months.
There will be regular check-ups and monitoring for up to 10 years.
The study aims to see if the drugs improve outcomes compared to standard observation.

Who may be eligible?

This study is looking for adults aged 18 or over who have recently had surgery to remove a type of skin cancer called melanoma. Specifically, it's for those with 'Stage IIB' or 'IIC' melanoma. A key requirement is that your melanoma must have a specific gene change, known as a BRAF V600E/K mutation, which will be checked from your tumour sample.

To be considered, your melanoma must have been completely removed by surgery, and scans must show that you are currently free of cancer. You should also have had a check of your lymph nodes (called a sentinel node biopsy) which showed no cancer cells. Your treatment team will need to ensure you've recovered well from your surgery and that your organs, like your heart, kidneys, and liver, are all working properly.

Certain health conditions or medications might mean you can't join the study, as they could affect how safe or effective the treatment is for you. Your doctor will carefully review your medical history and test results to see if you meet all the necessary requirements.

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?
Have you had surgery for Stage IIB or IIC melanoma?
Has your doctor confirmed your melanoma has a 'BRAF V600E/K mutation'?
Are you currently free of melanoma after surgery, as confirmed by scans?
Are you able to take daily medication by mouth?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups: either receiving a combination of two drugs (encorafenib and binimetinib) or two inactive dummy pills (placebos). You would take these medications or placebos by mouth every day for 12 months.

During this 12-month treatment period, you would have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and see how you are responding. After the 12-month treatment finishes, you will continue to have follow-up visits for many years, potentially up to 10 years, to keep an eye on your overall health and check if the melanoma returns. Throughout this time, researchers will also be looking for any new side effects that might appear.

Potential risks and benefits

Taking part in this study means you might receive a treatment that could potentially reduce the chance of your melanoma returning. However, like all medications, encorafenib and binimetinib can cause side effects. These can vary from mild to more serious, and your study team will discuss all known potential risks with you in detail. There is also a chance you might receive a placebo and get no direct benefit from the study drugs themselves, though you would still receive close medical monitoring. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (155)

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

Centro Oncologico Korben
Unverified
CABA, Argentina
Centro de Investigaciones Medicas Mar del Plata
Verified postcode
Mar del Plata, Argentina
Fundacion CIDEA
Unverified
Ciudad Autonoma Bs As, Argentina
Sanatorio Britanico S.A.
Verified postcode
Rosario, Argentina
Instituto de Oncologia de Rosario
Verified postcode
Rosario, Argentina
Hospital Aleman
Unverified
Ciudad Autonoma Buenos Aires, Argentina
Instituto Medico Especializado Alexander Fleming
Unverified
Ciudad Autonoma Buenos Aires, Argentina
Clinica Adventista Belgrano
Unverified
Ciudad Autonoma Buenos Aires, Argentina
Westmead Hospital
Verified postcode
Sydney, Australia
Melanoma Institute Australia
Verified postcode
Wollstonecraft, Australia
Princess Alexandra Hospital
Verified postcode
Woolloongabba, Australia
Adelaide Oncology & Haematolog, Calvary North Adelaide Hospital
Verified postcode
North Adelaide, Australia

Common questions

What is a BRAF V600E/K mutation?

It's a specific change in a gene within the melanoma cells. This change can sometimes make the cancer grow more aggressively, and certain drugs are designed to target it.

What is 'adjuvant setting'?

This means giving treatment after the main treatment (like surgery) to try and reduce the risk of the cancer coming back.

What does 'randomised' mean?

It means you'll be put into one of the study groups by chance, like flipping a coin. This helps make the study fair.

What is a 'placebo'?

A placebo is an inactive dummy pill that looks just like the study drug. It's used to compare the real drug's effects accurately.

How long will I be followed in the study?

Even after treatment finishes, you will be followed for up to 10 years to see the long-term effects of the study and monitor your health.