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Study for Patients with Metastatic Colorectal Cancer with BRAF V600E Mutation Using Encorafenib, Cetuximab, and Chemotherapy Combination

Verified siteRegistered drugNo placebo
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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 colorectal cancer that has a specific genetic change known as the BRAF V600E mutation. The study is testing a combination of treatments to see how effective they are in treating this cancer. The main treatments being studied are encorafenib and cetuximab, which are being used together with or without additional chemotherapy. Chemotherapy is a type of cancer treatment that uses drugs to stop the growth of cancer cells. The chemotherapy drugs involved in this study include irinotecan, oxaliplatin, fluorouracil, capecitabine, and calcium folinate. Another drug, bevacizumab, may also be used in some cases.

The purpose of the study is to compare the effectiveness of these treatments against the standard care usually given to patients with this type of cancer. The study will also look at the safety and tolerability of the treatments, which means checking for any side effects and how well patients can handle the treatment. Participants in the study will receive the treatments over a period of time, and their health will be monitored closely to see how the cancer responds to the treatment.

Throughout the study, participants will be given either the new combination of treatments or the standard care, which is the usual treatment given for this type of cancer. The study aims to find out if the new combination of treatments can help improve outcomes for patients with metastatic BRAF V600E mutant colorectal cancer, which is a form of cancer that has spread to other parts of the body. The results of this study could help improve treatment options for patients with this specific type of colorectal cancer in the future.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, confirmation of a specific genetic mutation in the BRAF gene is required. This involves testing tumor tissue or blood samples to ensure eligibility.

    Participants must have a confirmed diagnosis of colorectal cancer with a specific genetic mutation (BRAF V600E).

  2. Step 2

    Safety lead-in phase

    The initial phase focuses on determining the safety and tolerability of the treatment combinations. This involves monitoring for any adverse effects.

    Participants receive a combination of encorafenib and cetuximab with chemotherapy regimens such as mFOLFOX6 or FOLFIRI.

  3. Step 3

    Phase 3 treatment

    Participants are randomly assigned to different treatment groups. One group receives encorafenib and cetuximab with mFOLFOX6, while another group receives standard care.

    The effectiveness of the treatments is compared by measuring progression-free survival and overall response rates.

  4. Step 4

    Cohort 3 treatment

    In this phase, participants receive encorafenib and cetuximab with FOLFIRI, or FOLFIRI with or without bevacizumab.

    The focus is on comparing the effectiveness of these treatments by measuring overall response rates.

  5. Step 5

    Medication administration

    Medications are administered either orally or intravenously. Encorafenib is taken orally, while cetuximab, irinotecan, oxaliplatin, and bevacizumab are given through intravenous infusion.

    The specific dosage and frequency depend on the treatment regimen assigned.

  6. Step 6

    Monitoring and follow-up

    Regular monitoring is conducted to assess the treatment's effectiveness and any side effects. This includes clinical evaluations, laboratory tests, and imaging studies.

    Participants are required to attend scheduled visits and comply with the treatment plan throughout the study duration.

Who can join the trial?

9 criteria

  • Participants must be **male or female** and at least **18 years old**. In some countries, participants can be as young as **16 years old** if allowed.
  • Participants must have a **body weight** of at least **40 kg** (about 88 pounds).
  • Participants must have **colorectal adenocarcinoma**, which is a type of cancer that starts in the colon or rectum.
  • Participants must have **Stage IV metastatic disease**, meaning the cancer has spread to other parts of the body. Those with a limited spread of cancer, called **oligometastatic disease**, can also join if they have measurable disease.
  • Participants must provide a **tumor sample** for testing. This sample can be from a previous biopsy or surgery done within the last two years.
  • Participants must be able to **give informed consent**, meaning they understand and agree to the study's requirements. If under guardianship, consent from a legal guardian is needed.
  • Participants must meet all **Molecular Prescreening** criteria, which are specific tests done before the main study.
  • Participants must be willing and able to **attend all scheduled visits** and follow the study's treatment plan and procedures.
  • Participants must have a **BRAF V600E mutation** in their tumor tissue or blood. This is a specific change in the cancer cells that the study is focusing on.

Who cannot join the trial?

16 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not recovered from previous treatments or surgeries.
  • Patients with serious heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that need treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer in the past, unless it was treated and is not active now.
  • Patients who are taking certain medications that might interfere with the study treatment.
  • Patients with known allergies to the study drugs.
  • Patients who have participated in another clinical trial recently.
  • Patients with certain mental health conditions that might affect their ability to participate.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have had a major surgery recently.
  • Patients with certain blood disorders.
  • Patients with severe liver or kidney problems.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

  • Encorafenib

    is a medication used in this trial to target a specific mutation in cancer cells known as BRAF V600E. It works by blocking the activity of a protein that promotes cancer cell growth, helping to slow down or stop the progression of the cancer.

  • Cetuximab

    is a therapy that targets a protein on the surface of cancer cells called EGFR. By binding to this protein, cetuximab can help prevent the cancer cells from growing and dividing.

  • mFOLFOX6

    is a combination chemotherapy regimen that includes several drugs working together to kill cancer cells. It is often used to treat colorectal cancer and includes medications that interfere with the DNA of cancer cells, preventing them from multiplying.

  • FOLFIRI

    is another chemotherapy regimen used in this trial. It combines different drugs to attack cancer cells in various ways, aiming to reduce the size of tumors and slow the spread of cancer.

  • Bevacizumab

    is a medication that works by inhibiting the growth of blood vessels that supply nutrients to tumors. By blocking this blood supply, bevacizumab can help starve the cancer cells and slow their growth.

What is already known about the treatment

  • Encorafenib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating colorectal cancer with a specific genetic mutation known as BRAF V600E. It is often used in combination with other drugs like cetuximab and chemotherapy. Encorafenib works by inhibiting a protein called BRAF, which is involved in cell growth, thereby slowing down or stopping the growth of cancer cells. It is classified as a BRAF inhibitor and is part of targeted cancer therapies.

  • Cetuximab

    This medication is given through an intravenous infusion and is being evaluated in combination with encorafenib and chemotherapy for treating metastatic colorectal cancer with the BRAF V600E mutation. Cetuximab targets the epidermal growth factor receptor (EGFR) on the surface of cancer cells, blocking signals that promote cell division and growth. It is classified as a monoclonal antibody and is used in targeted cancer therapy.

Investigated diseases

Colorectal Cancer (BRAF V600E-mutant mCRC) – This is a type of cancer that begins in the colon or rectum and is characterized by a specific genetic mutation known as BRAF V600E. This mutation can lead to uncontrolled cell growth and division, contributing to the development and progression of cancer. The disease often starts as a small growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade deeper layers of the colon or rectum and spread to nearby lymph nodes or other parts of the body. The presence of the BRAF V600E mutation is associated with a more aggressive form of colorectal cancer, which may influence the disease's behavior and response to certain treatments.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509405-77-00Protocol codeC4221015Estimated enrolment718 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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