Recruiting

Study of encorafenib and cetuximab treatment for patients with BRAF V600E-mutant metastatic colorectal cancer who previously responded to BRAF inhibitor therapy

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What is this trial about?

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

This study focuses on patients with metastatic colorectal cancer who have a specific genetic change called BRAF V600E mutation. These patients have previously received and responded to treatment that included a BRAF inhibitor. The study will test a combination of two medications: encorafenib (taken by mouth) and cetuximab (given through a vein) as a retreatment option.

The purpose of this research is to determine how well this combination therapy works when given again to patients who have previously benefited from similar treatment but whose cancer has since progressed. The study will measure how long patients remain without their cancer getting worse, particularly during the first four months of treatment.

During this single-group study, all participants will receive both medications. The treatment can continue for up to 36 months, depending on how well it works and how well it is tolerated. Throughout the study, doctors will monitor patients' health through regular medical examinations and tests to check for any side effects and to see how the treatment is working.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medication phase
You will receive a combination of two medications: encorafenib (taken orally) and cetuximab (given intravenously)
This treatment is designed for patients with BRAF V600E-mutant metastatic colorectal cancer who have previously responded to BRAF inhibitor treatment
The treatment will be administered after at least 4 months have passed since your last BRAF inhibitor treatment
Step 2
Regular monitoring phase
Your progress will be monitored regularly through medical examinations
The medical team will assess your condition using RECIST criteria (a standardized way to measure if tumors are responding to treatment)
Regular laboratory tests will be conducted to check your blood count, liver function, and kidney function
Your heart function will be monitored through ECG tests
Any side effects will be recorded and assessed using standardized criteria
Step 3
Four-month assessment
At the 4-month mark, a detailed assessment will be conducted to evaluate how well the treatment is working
This evaluation will include imaging tests to check if the cancer has progressed
The medical team will determine if the treatment should continue based on your response
Step 4
Ongoing treatment phase
Treatment will continue as long as you are responding positively and not experiencing severe side effects
Regular assessments will continue throughout the treatment period
The study is planned to continue until May 2029

Who can join the trial?

15 criteria

Must be 18 years or older
Must provide signed and dated informed consent form
Must have confirmed metastatic colorectal cancer (cancer that has spread from colon to other parts of body)
Must have confirmed BRAF V600E mutation (specific genetic change in tumor)
Must be able to take oral medications
Must have a good performance status (ECOG 0-1), meaning able to perform daily activities with minimal assistance
Must have adequate bone marrow function, including: - Sufficient white blood cells - Sufficient platelets - Sufficient hemoglobin levels
Must have proper liver and kidney function based on blood test results
Must have adequate heart function
Must have previously received at least 2 different treatment regimens for metastatic disease
Must have previously received and responded to treatment containing BRAF inhibitor for at least 4 months
Must have at least 4 months break since last BRAF inhibitor treatment
Must have measurable disease that can be evaluated by scans
Must have life expectancy of more than 12 weeks
Must use effective contraception during study and for 2 months after last study medication if able to conceive

Who cannot join the trial?

13 criteria

Prior treatment with encorafenib or cetuximab (these are medications used in cancer treatment)
Active brain metastases (cancer that has spread to the brain) that are untreated or unstable
History of other cancers within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ
Major surgery within 4 weeks before starting the study treatment
Serious or uncontrolled medical conditions that could interfere with study participation
Known allergies or severe reactions to the study medications or their components
Pregnancy or breastfeeding
Active, uncontrolled infections
close
Heart problems including:
- Unstable angina (chest pain)
- Heart attack within the past 6 months
- Uncontrolled high blood pressure
- Participation in another clinical trial within 4 weeks before starting this study
- Any condition that would make the patient unable to comply with study requirements or follow-up visits

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Verified sites

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Hospital Vall d’Hebron
Barcelona, Spain

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Investigated drugs

Encorafenib is a targeted therapy medication that works by blocking a specific protein called BRAF when it has a certain mutation (V600E). This medication helps slow down or stop the growth of cancer cells in colorectal cancer that has this specific genetic change. Cetuximab is a type of medication called a monoclonal antibody. It works by targeting a protein called EGFR (epidermal growth factor receptor) that is found on the surface of cancer cells. By blocking this protein, cetuximab helps prevent cancer cells from growing and spreading. It is given through an intravenous infusion. These medications are used together as a combination therapy for patients with colorectal cancer that has spread to other parts of the body (metastatic), specifically in cases where the cancer has a BRAF V600E mutation and the patient has previously responded to similar treatments.

Encorafenib

What is already known about the treatment

Encorafenib
A targeted oral medication that works as a BRAF kinase inhibitor, specifically designed to treat cancers with BRAF V600E mutations, including metastatic colorectal cancer. It functions by blocking the abnormal BRAF protein that drives cancer growth, effectively slowing down or stopping the proliferation of cancer cells. This medication is typically administered in combination with cetuximab as part of a targeted therapy regimen and has shown promising results in clinical trials for patients who have previously responded to BRAF inhibitor-based treatments.
Cetuximab
An intravenous monoclonal antibody medication that targets the epidermal growth factor receptor (EGFR) on cancer cells, commonly used in the treatment of metastatic colorectal cancer. It works by binding to EGFR on the surface of cancer cells, blocking growth signals and preventing cancer cell multiplication. This medication is administered through infusion in a clinical setting and is often used in combination with other targeted therapies, particularly in patients with specific genetic mutations like BRAF V600E.

Investigated diseases

Metastatic Colorectal Cancer (mCRC) with BRAF V600E mutation - A form of advanced colorectal cancer where cancer cells have spread beyond the original site to other parts of the body. This specific type is characterized by a mutation in the BRAF gene called V600E, which affects how cancer cells grow and divide. The disease begins in the colon or rectum and develops when healthy cells acquire this particular genetic mutation, leading to uncontrolled cell growth. As the disease progresses, cancer cells can break away from the primary tumor and travel through the blood or lymphatic system to form new tumors in other organs.