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Study on Encorafenib and Cetuximab for Patients with BRAF V600E-Mutated Localized Colon or Upper Rectum Cancer

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

A rare form of colon or upper rectum cancer that carries a specific genetic change called BRAF V600E-mutated localized colon or upper rectum cancer is being studied. The trial tests a combination of two medicines: the oral tablet encorafenib and the intravenously given infusion cetuximab. The goal of the study is to find out whether this drug combination is safe and can be used before surgery, a treatment approach known as neoadjuvant therapy.

Participants will take the oral capsule and receive the infusion over several weeks prior to having surgery to remove the tumor. After surgery, they will be monitored for any side effects and for how well they recover. Doctors will use imaging such as a CT scan to check how the tumor responds, and they will continue to follow the patients to see how they feel and whether the cancer returns.

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, informed consent must be signed. This confirms understanding and agreement to participate.

    Eligibility is confirmed based on specific health criteria, including age, medical history, and current health status.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current state of the cancer. This includes imaging tests and laboratory evaluations to confirm the presence of the BRAF V600E mutation.

  3. Step 3

    Treatment phase

    The treatment involves a combination of two medications: cetuximab and encorafenib.

    Cetuximab is administered through an intravenous infusion. The frequency and dosage are determined by the healthcare provider based on individual needs.

    Encorafenib is taken orally in the form of hard capsules. The dosage is 75 mg, and the frequency is specified by the healthcare provider.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and laboratory evaluations.

    The primary goal is to evaluate the tumour regression rate using specific criteria.

  5. Step 5

    Surgery

    If the tumour shows significant regression, surgery may be performed to remove the remaining cancerous tissue.

    Post-surgery, a centralised review is conducted to assess the outcome.

  6. Step 6

    Follow-up

    After surgery, follow-up appointments are scheduled to monitor recovery and overall health.

    The study also evaluates overall survival, progression-free survival, and quality of life.

Who can join the trial?

15 criteria

  • The patient must give their permission to participate by signing a consent form.
  • The patient must have certain blood test results: serum total bilirubin should be 25 or less, and ALT and/or AST should be 2.5 times or less than the upper normal limit.
  • The patient's heart function should be satisfactory, with a QT interval (a measure of heart rhythm) of 480 milliseconds or less.
  • The patient must be able to take medicine by mouth.
  • Female patients must be postmenopausal for at least one year, surgically unable to have children for at least six weeks, or use effective birth control. Male patients must also use effective birth control for two months after treatment.
  • Female patients who can have children must have a negative pregnancy test before joining the study.
  • The patient must be covered by the French Social Security system.
  • The patient must be between 18 and 75 years old at the time of giving consent.
  • The patient must have a specific type of colon or upper rectum cancer that is operable and confirmed by a biopsy to have a BRAF V600E mutation.
  • The cancer must be at a certain stage, with a tumor that extends 5 millimeters or more outside the wall of the colon or rectum, as seen on a CT scan.
  • The patient must be able to provide a sufficient sample of their tumor for analysis.
  • The patient must have a WHO performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
  • The patient must have satisfactory blood cell counts: neutrophils (a type of white blood cell) of 1,500 or more, platelets of 100,000 or more, and hemoglobin of 9 grams per deciliter or more.
  • The patient must have a creatinine clearance (a measure of kidney function) greater than 50 milliliters per minute.
  • The patient's serum magnesium levels must be within normal limits.

Who cannot join the trial?

9 criteria

  • Patients who do not have a BRAF V600E mutation in their colon or upper rectum cancer. This is a specific change in the cancer cells that the study is focusing on.
  • Patients whose cancer is not localized, meaning the cancer has spread to other parts of the body.
  • Patients who have a RAS mutation. This is another type of change in the cancer cells that is not suitable for this study.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who are pregnant or breastfeeding.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had certain treatments recently that might affect the study results.
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Investigated drugs

  • Encorafenib

    is a medication used in this trial to target and inhibit a specific mutation known as BRAF V600E. This mutation is found in some types of cancer, including certain colon cancers. By blocking the activity of this mutation, encorafenib aims to slow down or stop the growth of cancer cells.

  • Cetuximab

    is another medication used in the trial, which works by targeting a protein on the surface of cancer cells called EGFR (epidermal growth factor receptor). By binding to this protein, cetuximab helps to prevent the cancer cells from growing and dividing. It is used in combination with encorafenib to enhance the treatment's effectiveness against the cancer.

What is already known about the treatment

  • Encorafenib

    Encorafenib is administered orally and is currently being studied in clinical trials for its effectiveness in treating BRAF V600E-mutated localized colon or upper rectum cancer. It is primarily indicated for use in combination with other medications to target specific cancer mutations. At the molecular level, encorafenib works by inhibiting the BRAF protein, which is involved in cell growth and division, thereby slowing down or stopping the growth of cancer cells. It is classified as a BRAF inhibitor in pharmacology.

  • Cetuximab

    Cetuximab is administered intravenously and is being evaluated in clinical trials for its role in treating BRAF V600E-mutated localized colon or upper rectum cancer. It is used in combination with other drugs to enhance its therapeutic effects. Cetuximab works by binding to the epidermal growth factor receptor (EGFR) on the surface of cancer cells, blocking the signals that promote cell growth and survival. It is classified as an EGFR inhibitor in pharmacological terms.

Investigated diseases

BRAF V600E-Mutated Localized Colon or Upper Rectum Cancer – This is a type of cancer that occurs in the colon or the upper part of the rectum and is characterized by a specific genetic mutation known as BRAF V600E. This mutation leads to changes in the cells that cause them to grow uncontrollably, forming a tumor. The cancer is considered localized, meaning it has not spread to other parts of the body. Over time, the tumor may grow larger and potentially invade nearby tissues. The progression of this cancer can vary, but it typically involves the gradual worsening of symptoms related to bowel function. The presence of the BRAF V600E mutation can influence the behavior and progression of the cancer.
Trial detailsLast updated 13 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514107-34-00Protocol codeFFCD 2006 NEORAFEstimated enrolment30 patientsSponsorFondation Franc.Cancerologie Digestive

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