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Study on Encorafenib, Cetuximab, and FOLFIRI for Patients with BRAF V600E Mutated Metastatic Colorectal Cancer After Progression on Encorafenib and Cetuximab

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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 known as metastatic colorectal cancer that has a specific genetic change called the BRAF V600E mutation. This mutation can make the cancer more aggressive and harder to treat. The study is testing a combination of treatments to see if they can help patients whose cancer has continued to grow despite previous treatment. The treatments being tested include encorafenib, cetuximab, and a combination of drugs known as FOLFIRI, which includes irinotecan, fluorouracil, and folinic acid. These medications are given to help stop the cancer from growing and spreading.

The purpose of the study is to determine how effective this combination of treatments is for patients with this specific type of cancer. Patients will receive the treatments over a period of up to 24 months. The medications will be administered either through an IV infusion or taken orally, depending on the specific drug. Throughout the study, patients will have regular check-ups and scans to monitor the progress of their cancer and to see how well the treatment is working. The study aims to find out if this combination can help patients live longer without their cancer getting worse.

Participants in the study will be monitored for any side effects from the treatment, and the study will also look at how long patients live after starting the treatment. The study will help doctors understand if this combination of drugs can be a new option for treating patients with BRAF V600E mutated metastatic colorectal cancer. The results of this study could provide valuable information for future treatment strategies for this challenging type of cancer.

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

    Enrollment

    Upon joining the study, the patient will provide written consent to participate in the trial.

    The patient must meet specific health criteria, including adequate bone marrow, renal, hepatic, and cardiac function, and must be able to take oral medications.

  2. Step 2

    Initial assessment

    A baseline assessment will be conducted, including a pregnancy test for women of childbearing potential.

    The patient must have a confirmed diagnosis of colorectal adenocarcinoma with a BRAF V600E mutation and evidence of metastatic disease.

  3. Step 3

    Treatment initiation

    The treatment involves a combination of medications: irinotecan hydrochloride, fluorouracil, cetuximab, encorafenib, and folinic acid.

    Irinotecan, fluorouracil, cetuximab, and folinic acid are administered through an intravenous (IV) infusion, while encorafenib is taken orally.

  4. Step 4

    Treatment schedule

    The treatment is administered in cycles, with specific dosages and frequencies determined by the study protocol.

    The patient will receive regular assessments to monitor the response to treatment and any side effects.

  5. Step 5

    Progress monitoring

    Tumor assessments will be conducted every 8 weeks using CT scans of the chest and abdomen to evaluate disease progression.

    The primary goal is to assess the 6-month progression-free survival rate, which measures the time the patient remains alive without disease progression.

  6. Step 6

    Completion and follow-up

    The study will continue until disease progression or the patient decides to withdraw.

    Follow-up visits will be scheduled to monitor the patient's health and any long-term effects of the treatment.

Who can join the trial?

24 criteria

  • Provide a signed agreement to participate in the study.
  • Have a life expectancy of at least 3 months.
  • Have an ECOG Performance Status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
  • Have adequate bone marrow function, which includes:
    • Absolute neutrophil count (ANC) of at least 1.5 x 109/L. Neutrophils are a type of white blood cell important for fighting infections.
    • Platelet count of at least 100 x 109/L. Platelets help with blood clotting.
    • Hemoglobin level of at least 9.0 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
    • Have adequate kidney function, with a serum creatinine level not more than 1.5 times the normal limit, or a creatinine clearance of at least 50 mL/min. Creatinine is a waste product filtered by the kidneys.
    • Have adequate liver function, which includes:
      • Serum total bilirubin level not more than 1.5 times the normal limit. Bilirubin is a substance made during the breakdown of red blood cells.
      • ALT and AST levels not more than 2.5 times the normal limit, or 5 times if there are liver metastases. ALT and AST are enzymes that help assess liver health.
      • Have adequate heart function, with a QTcF value of 480 milliseconds or less. QTcF is a measure of heart rhythm.
      • Provide a sample of tumor tissue that has not been treated before.
      • Be able to take medications by mouth.
      • Men with female partners who can become pregnant must agree to use effective birth control during the study and for 180 days after the last dose. Abstinence is acceptable if it is the usual lifestyle choice.
      • Women who can become pregnant must have a negative pregnancy test before starting the study.
      • Be at least 18 years old.
      • Women who can become pregnant must agree to use effective birth control during the study and for 180 days after the last dose. Abstinence is acceptable if it is the usual lifestyle choice.
      • Be willing and able to follow the study rules.
      • Have a confirmed diagnosis of colorectal adenocarcinoma, a type of cancer that starts in the colon or rectum.
      • Have evidence of cancer that has spread to other parts of the body.
      • Have measurable disease according to RECIST 1.1 criteria, which is a standard way to measure how well a cancer treatment works.
      • Have a BRAF V600E mutation in the tumor tissue, which is a specific change in the cancer cells.
      • Have experienced disease progression while on treatment with EC in the second line setting. This means the cancer got worse after receiving a specific treatment.
      • Have had a best response of complete response (CR), partial response (PR), or stable disease (SD) lasting at least 3 months to previous treatment with EC.
      • Be fit for another treatment line with FOLFIRI, a combination of cancer drugs. Patients who have had certain drugs before are eligible if they have recovered from severe side effects.

Who cannot join the trial?

4 criteria

  • Patients who do not have the specific genetic change called BRAF V600E in their cancer.
  • Patients who have not previously been treated with a combination of drugs called EC and FOLFIRI for their cancer.
  • 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

  • Encorafenib

    is a medication used to treat certain types of cancer by targeting and inhibiting specific proteins involved in cancer cell growth. In this trial, it is used to help manage metastatic colorectal cancer that has a specific genetic mutation known as BRAF V600E.

  • Cetuximab

    is a medication that works by blocking the action of a protein called epidermal growth factor receptor (EGFR), which is involved in the growth and spread of cancer cells. It is used in combination with other treatments to help control the progression of metastatic colorectal cancer.

  • FOLFIRI

    is a combination chemotherapy regimen that includes three different medications: folinic acid, fluorouracil, and irinotecan. This combination is used to treat colorectal cancer by interfering with the DNA of cancer cells, preventing them from growing and dividing. In this trial, FOLFIRI is used alongside other treatments to enhance their effectiveness against 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 metastatic colorectal cancer with the BRAF V600E mutation. It is primarily used in combination with other medications like Cetuximab and FOLFIRI. Encorafenib works by inhibiting the BRAF protein, which is involved in cell growth, 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 used in combination with other treatments for metastatic colorectal cancer with the BRAF V600E mutation. It is an established medication in oncology, often used alongside Encorafenib and FOLFIRI. Cetuximab works by targeting the epidermal growth factor receptor (EGFR) on cancer cells, blocking signals that promote tumor growth. It is classified as a monoclonal antibody in pharmacology.

Investigated diseases

Metastatic Colorectal Cancer with BRAF V600E Mutation – This is a type of colorectal cancer that has spread to other parts of the body and contains a specific genetic mutation known as BRAF V600E. This mutation can lead to uncontrolled cell growth and division, contributing to cancer progression. Patients with this mutation often experience a more aggressive form of the disease. The cancer typically progresses through stages, starting from the colon or rectum and eventually spreading to distant organs. The presence of the BRAF V600E mutation can influence the behavior of the cancer and its response to certain treatments. Understanding the mutation is crucial for developing targeted therapies to manage the disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508615-24-00Protocol codeECLYPseEstimated enrolment25 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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