RecruitingOBSERVATIONAL

BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment

This study, called BERING CRC, is investigating a specific two-drug treatment (encorafenib and cetuximab) for a type of advanced bowel cancer. This cancer has a gene change called BRAFV600E, which generally means a poorer outlook. Doctors already know these drugs can help, but this study wants to see how they work for people in their everyday lives, outside of strict clinical trials. Researchers will look at how effective the treatment is, how it affects patients' quality of life, and any side effects. This will help them understand more about using these medicines in a wider group of patients in countries like Germany, Austria, and Switzerland.

At a glance

Status

Recruiting

Sponsor

Pierre Fabre Pharma GmbH

Enrolment target

500

Start

03 Sep 2020

Estimated completion

01 Jan 2027

Metastatic Colorectal Carcinoma

What is this study about?

This study, called BERING CRC, is looking at a new way to treat advanced bowel cancer (also known as metastatic colorectal carcinoma). Specifically, it's for people whose cancer has a particular change in a gene called BRAFV600E. This gene change can make the cancer harder to treat and generally means a tougher road ahead compared to bowel cancer without this change.

Previous studies have shown that traditional treatments for this specific type of bowel cancer often don't work as well as doctors would like. This has led to trying new combinations of drugs that target the cancer in different ways. One big study, called BEACON CRC, found that combining two drugs, encorafenib and cetuximab, could improve how long people live and how well their cancer responds compared to older treatments.

BERING CRC isn't a strict clinical trial where patients are randomly assigned to different treatments. Instead, it's a 'real-world' study. This means it's observing how doctors are already using encorafenib and cetuximab in their day-to-day practice. The main goal is to gather more information on how well the treatment works, how it affects patients' overall quality of life, and what side effects people experience when these drugs are used in a broader patient population across Germany, Austria, and Switzerland. This helps doctors get a clearer picture of the treatment's true impact outside of strict research settings.

Key takeaways

Study focuses on advanced bowel cancer with a specific gene change (BRAFV600E mutation).
It observes how two drugs, encorafenib and cetuximab, work in everyday patient care.
Aims to understand real-world effectiveness, quality of life, and safety.
Not a traditional interventional trial; no new treatments are given.
Your doctor must have already decided on this treatment for you.
Information gathered will help improve future treatment understanding.

Who may be eligible?

To be considered for this study, you must have advanced bowel cancer that has spread to other parts of your body. Your cancer also needs to have a specific genetic change called BRAFV600E, and you should have already had some other cancer treatment.

Your doctor must have already decided that the best treatment for you is the combination of encorafenib and cetuximab, based on standard medical guidelines. This decision must have been made before you agree to join the study. You also need to be at least 18 years old and willing to give your written permission for your medical information to be used in the study, while keeping your identity private.

However, you can't join if you've already had more than two rounds of treatment for your advanced cancer, or if you've previously taken similar types of drugs (RAF or MEK inhibitors). You also can't take part if you have any medical reasons that prevent you from safely taking encorafenib and cetuximab, or if you are already in another clinical trial.

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 I have advanced bowel cancer (metastatic colorectal carcinoma)?
Does my cancer have the BRAFV600E gene change?
Have I already had some prior treatment for my advanced cancer?
Has my doctor already decided for me to take encorafenib and cetuximab?
Am I at least 18 years old?
Am I willing to have my health information used anonymously for research?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given a new medicine or asked to do anything different from your usual treatment. The study simply collects information about your experiences while you're taking the encorafenib and cetuximab treatment that your doctor has already prescribed for you. This means there are no extra doctor visits, tests, or changes to your medication schedule specifically for the study. The researchers will simply gather details from your regular medical appointments about how you're responding to the treatment, any side effects you experience, and how your quality of life is affected. The study doesn't specify an exact duration for each patient's involvement, as it depends on how long you continue this treatment as part of your standard care.

Potential risks and benefits

The main benefit of participating in this study is that you would be contributing valuable information that helps doctors better understand how encorafenib and cetuximab work in real-world settings for patients like you. This knowledge can improve future care for others with advanced bowel cancer. Since this is an observational study, you won't undergo any extra procedures or treatments solely for the study, so there are no additional risks beyond those associated with the treatment itself, which your doctor will discuss with you. You have the right to withdraw your consent and stop participating in the study at any time, without it affecting your medical care.

Locations (70)

Clinic
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Braunau am Inn, Austria· Recruiting
Clinic
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Linz, Austria· Recruiting
Clinic
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Feldkirch, Austria· Recruiting
Clinic
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Vienna, Austria· Recruiting
Practice
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Offenburg, Germany· Recruiting
Medical Care Centre
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Ulm, Germany· Recruiting
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Ulm, Germany· Recruiting
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Augsburg, Germany· Recruiting
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Donauwörth, Germany· Recruiting
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Erlangen, Germany· Recruiting
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München, Germany· Recruiting
Practice
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Würzburg, Germany· Recruiting

Common questions

What kind of bowel cancer is this study for?

This study is for advanced bowel cancer that has spread, and specifically for patients whose cancer has a gene change called BRAFV600E.

Are the treatments in this study new or experimental?

No, the treatments (encorafenib and cetuximab) are already approved. This study is just observing how they work in real-life medical practice.

Will I have to take any extra medicines if I join?

No, you will only take the medicines your doctor has already prescribed as part of your standard care. The study doesn't involve giving new medicines.

Will joining this study change my regular doctor's appointments?

No, your regular doctor's appointments and treatments will continue as usual. The study simply collects information from these existing visits.

Why is this type of study important?

It helps doctors understand how treatments work in a broader group of patients in everyday settings, giving a more complete picture than strict clinical trials alone.

How to find out more

Marion Schmoll

marion.schmoll@iomedico.com +4976115242627 Official trial record

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