Recruiting

Study on Bevacizumab, Encorafenib, and Cetuximab for Patients with BRAF-V600E Mutated Metastatic Colorectal Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called metastatic colorectal cancer, which is a form of cancer that starts in the colon or rectum and spreads to other parts of the body. The study is investigating a combination of treatments to see how effective they are in treating this cancer. The treatments being tested include bevacizumab, encorafenib (also known by its code name LGX818), and cetuximab. These medications are used together to target specific pathways in cancer cells that help them grow and spread.

The purpose of the study is to evaluate how well this combination of drugs works in patients who have a specific mutation in their cancer called BRAF V600E. This mutation is known to affect how the cancer behaves and responds to treatment. The study will also look at the safety of these medications when used together, especially in the early stages of the trial. Participants will receive these treatments over a period of time, and their health will be monitored closely to see how the cancer responds and to check for any side effects.

During the trial, patients will receive the medications either through an infusion, which is a way of delivering the drug directly into the bloodstream, or in capsule form. The study aims to provide valuable information on whether this combination of treatments can help control the cancer and improve the quality of life for patients with this specific type of colorectal cancer. The trial will continue for several years to gather enough data to make informed conclusions about the effectiveness and safety of the treatment.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a confirmed diagnosis of metastatic colorectal cancer with a BRAF V600E mutation.
The study is designed for those who have experienced disease progression after one or two prior treatments.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the current health status and establish a baseline for future comparisons.
This includes imaging tests and laboratory evaluations to assess the extent of the disease.
Step 3
Treatment phase
The treatment involves a combination of three medications: cetuximab, bevacizumab, and encorafenib.
Cetuximab is administered as an intravenous infusion. The dosage and frequency are determined by the healthcare provider based on individual needs.
Bevacizumab is also given as an intravenous infusion, with the dosage and schedule tailored to the patient's condition.
Encorafenib is taken orally in the form of hard capsules. The dosage is prescribed by the healthcare provider.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment and manage any side effects.
This includes periodic imaging tests and laboratory evaluations to track disease progression and treatment efficacy.
Step 5
End of treatment
The treatment continues until disease progression or unacceptable side effects occur.
A final assessment is conducted to evaluate the overall response to the treatment.
Step 6
Post-treatment follow-up
After the treatment phase, follow-up visits are scheduled to monitor long-term health and any delayed side effects.
These visits include clinical evaluations and may involve additional imaging tests.

Who can join the trial?

6 criteria

The patient must have **metastatic colorectal cancer**. This means the cancer started in the colon or rectum and has spread to other parts of the body.
The cancer must have a specific change in the genes called the **BRAF V600E mutation**. This is a change in the DNA of the cancer cells that can affect how the cancer grows.
The patient must be able to receive a medicine called **cetuximab** based on the specific characteristics of their cancer, known as **tumor RAS status**. This is a test to see if the cancer has certain genetic features.
The cancer must have gotten worse after trying one or two different treatments for the metastatic cancer.
Both men and women can participate in the study.
The study includes adults, which generally means people who are 18 years or older.

Who cannot join the trial?

5 criteria

Patients who have not been diagnosed with metastatic colorectal cancer. This is a type of cancer that starts in the colon or rectum and has spread to other parts of the body.
Patients who have not shown progression after one or two chemotherapy treatments specifically for BRAF V600E-mutant mCRC. This refers to a specific genetic mutation in the cancer cells.
Patients who are not within the specified age range for the study.
Patients who are not willing or able to follow the study procedures.
Patients who are part of a vulnerable population that the study is not designed to include.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Hospital Clinico San Carlos
Madrid, Spain
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Hospital De La Santa Creu I Sant Pau
Barcelona, Spain
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Hospital Del Mar
Barcelona, Spain

Trial locations

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Investigated drugs

Bevacizumab
is a medication used to slow the growth of new blood vessels. In this trial, it is used to help stop the cancer from growing by cutting off its blood supply.
Encorafenib
is a medication that targets specific proteins in cancer cells, particularly those with a BRAF V600E mutation. It helps to stop the cancer cells from growing and spreading.
Cetuximab
is a medication that targets a protein on the surface of cancer cells, which can help slow down or stop the growth of the cancer. It is used in combination with other medications to enhance its effectiveness.

What is already known about the treatment

Bevacizumab
Bevacizumab is administered intravenously and is currently used in the treatment of various cancers, including metastatic colorectal cancer. It is well-documented in medical literature as an angiogenesis inhibitor, meaning it works by blocking the growth of new blood vessels that tumors need to grow. Bevacizumab is classified as a monoclonal antibody and is often used in combination with other cancer therapies to enhance their effectiveness.
Encorafenib
Encorafenib is taken orally and is primarily used for treating certain types of cancer, such as BRAF V600E-mutated metastatic colorectal cancer. It is recognized in medical literature for its role as a BRAF inhibitor, which means it targets and inhibits the activity of the BRAF protein that is involved in cell growth. This medication is classified as a kinase inhibitor and is often used in combination with other drugs to improve treatment outcomes.
Cetuximab
Cetuximab is administered intravenously and is used in the treatment of cancers like metastatic colorectal cancer. It is well-established in medical literature as an epidermal growth factor receptor (EGFR) inhibitor, which means it blocks the signals that promote cancer cell growth. Cetuximab is classified as a monoclonal antibody and is frequently used in combination with other therapies to enhance its therapeutic effects.

Investigated diseases

Metastatic Colorectal Cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It often progresses through stages, starting in the lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs, such as the liver or lungs. The disease may cause symptoms like changes in bowel habits, blood in the stool, and abdominal discomfort. As it advances, it can lead to more severe symptoms depending on the organs affected. The progression of metastatic colorectal cancer can vary, with some patients experiencing rapid spread while others may have a slower progression. The disease is often monitored through imaging and other assessments to track its spread and impact on the body.