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Study on the Effectiveness and Safety of Cetuximab, Encorafenib, and Binimetinib for Patients with Advanced Colorectal Cancer with BRAF V600E Mutation

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 advanced colorectal cancer, specifically the kind that has a mutation known as BRAF V600E and is described as microsatellite stable (MSS). The study is investigating a treatment combination that includes three medications: Cetuximab, Encorafenib, and Binimetinib. These medications are being used together as an initial treatment to see if they can help make the cancer more manageable and possibly allow for surgical removal or other treatments aimed at curing the disease.

The purpose of the study is to evaluate how effective and safe this combination of medications is for patients with this specific type of colorectal cancer. Participants in the study will receive the treatment over a period of time, and their response to the treatment will be closely monitored. The study will look at whether the treatment can help shrink the cancer enough to allow for surgery or other procedures that could potentially remove or destroy the cancer completely.

Throughout the study, participants will be assessed to determine if they are eligible for these additional treatments. The study will also track how well the cancer responds to the treatment, how long patients remain free of cancer progression, and overall survival rates. Additionally, any side effects or complications from the treatment will be recorded to ensure the safety of the participants. The study aims to provide valuable information on the potential benefits of this treatment combination for patients with this specific type of colorectal cancer.

The research process

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

  1. Step 1

    Initiation of treatment

    Upon joining the study, the treatment begins with the administration of three medications: encorafenib, binimetinib, and cetuximab.

    Encorafenib is taken orally in the form of 75 mg hard capsules. The dosage and frequency will be determined by the study protocol.

    Binimetinib is also taken orally as 15 mg film-coated tablets. The dosage and frequency will be specified in the study protocol.

    Cetuximab is administered intravenously as a 5 mg/mL solution for infusion. The frequency and duration of administration will be outlined in the study protocol.

  2. Step 2

    Evaluation of treatment eligibility

    The eligibility for radical treatment is evaluated at 12 or 24 weeks after the first dose of the study treatment.

    This evaluation is conducted by a multidisciplinary tumor board (MTB) to determine if the patient can undergo surgery or any other therapeutic procedure with curative intent.

  3. Step 3

    Radical treatment

    If eligible, radical treatment is performed at least 2 weeks after the end of the EBC treatment and no later than 10 weeks after the latest CT evaluation.

    Radical treatment may include surgery or other procedures such as radiofrequency, cryotherapy, laser hyperthermia, stereotactic body radiotherapy, or chemoembolization.

  4. Step 4

    Follow-up and assessment

    The study will monitor overall response rate, tumor regression grade, progression-free survival, overall survival, and disease-free survival.

    Complications related to surgery or other therapeutic procedures will be assessed within 60 days after surgery.

    The study will also monitor the incidence and severity of adverse events and changes in clinical laboratory parameters and vital signs.

Who can join the trial?

14 criteria

  • Participants must be male or female and at least 18 years old.
  • Participants need to have good bone marrow function, which means having enough white blood cells, platelets, and hemoglobin in their blood.
  • Participants should have good liver and kidney function. This involves having normal levels of certain substances in the blood, like bilirubin, ALT, and AST, which are indicators of liver health, and creatinine clearance, which shows kidney function.
  • Participants must be able to swallow and absorb oral medications.
  • Participants must be able to understand and sign a consent form, agreeing to take part in the study.
  • Participants should be willing and able to attend all scheduled visits and follow the treatment plan and other study procedures.
  • Participants must have a type of colorectal cancer called adenocarcinoma, confirmed by a tissue test.
  • Participants must have a specific genetic change in their cancer called a BRAF V600E mutation, confirmed by standard medical guidelines.
  • Participants must have a type of cancer that is microsatellite stable (MSS) or has normal mismatch-repair (pMMR) function, confirmed by specific tests.
  • Participants must have colorectal cancer that fits one of these conditions:
    • Locally advanced cancer that cannot be removed by surgery at first but might be removable later, as decided by a team of doctors.
    • Cancer that has spread to a few places like the liver, lungs, lymph nodes, or the lining of the abdomen, and is either removable by surgery or might be removable later, as decided by a team of doctors.
    • Cancer that has come back after previous surgery and chemotherapy, with the possibility of being removed by surgery, as decided by a team of doctors.
    • Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
    • Participants must have cancer that can be measured or evaluated by the study doctor, using specific guidelines.

Who cannot join the trial?

4 criteria

  • Patients who do not have the specific type of colorectal cancer being studied, which is **BRAF V600E mutated** and **microsatellite stable (MSS)** advanced colorectal cancer.
  • Patients whose cancer is not initially resectable or potentially resectable. **Resectable** means that the cancer can be removed by surgery.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Cetuximab

    is a medication used in this trial to help treat advanced colorectal cancer. It works by targeting specific proteins on the surface of cancer cells, which can slow down or stop their growth. In this study, it is combined with other medications to see if it can improve the chances of successfully removing the cancer through surgery or other treatments.

  • Encorafenib

    is another medication used in the trial. It targets a specific mutation in the cancer cells known as BRAF V600E. By blocking this mutation, encorafenib can help stop the cancer cells from growing and spreading. It is used in combination with other drugs to enhance its effectiveness.

  • Binimetinib

    is included in the treatment plan to work alongside encorafenib. It targets a different pathway in the cancer cells, which can help to further inhibit their growth. By using binimetinib with encorafenib and cetuximab, the trial aims to see if this combination can make the cancer more treatable with surgery or other curative procedures.

What is already known about the treatment

  • Cetuximab

    Cetuximab is administered intravenously and is currently used in clinical trials to treat certain types of colorectal cancer. It is primarily indicated for BRAF V600E mutated and microsatellite stable advanced colorectal cancer. Cetuximab works by targeting the epidermal growth factor receptor (EGFR) on the surface of cancer cells, blocking signals that promote cancer cell growth. It is classified as a monoclonal antibody.

  • Encorafenib

    Encorafenib is taken orally and is being studied in combination therapies for colorectal cancer. It is used for BRAF V600E mutated and microsatellite stable advanced colorectal cancer. Encorafenib inhibits the BRAF protein, which is involved in sending signals that lead to cancer cell growth. It belongs to the class of BRAF inhibitors.

  • Binimetinib

    Binimetinib is administered orally and is part of ongoing research for treating colorectal cancer. It is indicated for BRAF V600E mutated and microsatellite stable advanced colorectal cancer. Binimetinib works by inhibiting the MEK enzymes, which are part of a pathway that helps cancer cells grow. It is classified as a MEK inhibitor.

Investigated diseases

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. The disease can spread to other parts of the body, a process known as metastasis. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others spread to distant organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502413-29-00Protocol codeTTD-21-02Estimated enrolment70 patientsSponsorAsociacion Grupo Tratamiento De Tumores Digestivos

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