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Study Comparing Amivantamab and Drug Combination for Patients with Recurrent or Metastatic Colorectal Cancer Without KRAS/NRAS and BRAF Mutations

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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 colorectal cancer, specifically in cases where the cancer has returned, cannot be surgically removed, or has spread to other parts of the body. The study is particularly interested in patients whose cancer does not have certain genetic mutations, specifically KRAS, NRAS, and BRAF wild-type mutations. The trial will explore the effectiveness of a new treatment combination involving a medication called Amivantamab and a chemotherapy regimen known as FOLFIRI, compared to another treatment combination using Cetuximab or Bevacizumab with FOLFIRI.

The purpose of the study is to compare how well these treatment combinations work in controlling the cancer. Participants will receive one of the treatment combinations and will be monitored over time to see how their cancer responds. The study will involve regular visits to the clinic for treatment and assessments, which will include various tests to check the progress of the cancer and the overall health of the participants.

Throughout the study, participants will receive their treatments through an infusion, which means the medication will be given directly into a vein. The study aims to provide valuable information on which treatment combination might be more effective for patients with this specific type of colorectal cancer. The trial will continue until enough information is gathered to make a clear comparison between the two treatment options.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The initial assessment involves confirming the diagnosis of colorectal cancer. The cancer must be of a specific type, known as KRAS/NRAS and BRAF wild-type, and must be recurrent, cannot be surgically removed, or has spread to other parts of the body.

    Eligibility is determined by previous treatment history, specifically having received one line of systemic therapy for metastatic colorectal cancer, with documented disease progression.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups. This process ensures that each participant has an equal chance of receiving either treatment option.

  3. Step 3

    Treatment administration

    Participants in the first group receive amivantamab in combination with a chemotherapy regimen known as FOLFIRI. Amivantamab is administered via subcutaneous injection.

    Participants in the second group receive a combination of cetuximab and bevacizumab with FOLFIRI. Both cetuximab and bevacizumab are administered through intravenous infusion.

    The frequency and dosage of these medications are determined by the study protocol and are administered under medical supervision.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes imaging tests and other assessments as required by the study protocol.

    Participants are monitored for progression-free survival (PFS) and overall survival (OS) as primary endpoints of the study.

  5. Step 5

    Completion of study

    The study is estimated to conclude by October 2029. Participants will continue to be monitored until the study's end date or until they meet criteria for discontinuation.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of a type of cancer called adenocarcinoma of the colon or rectum. This means the cancer started in the glandular cells of these areas.
  • The cancer must be recurrent (has come back), unresectable (cannot be removed by surgery), or metastatic (has spread to other parts of the body).
  • The tumor must be of a specific type called KRAS, NRAS, and BRAF wild-type, which means it does not have certain genetic mutations.
  • Must have already received one type of treatment for metastatic colorectal cancer and have shown disease progression, meaning the cancer has continued to grow or spread.
  • Must be 18 years or older and have a performance status of 0-1 on the ECOG scale, which measures how well a person can perform daily activities.
  • Must have at least one measurable tumor according to a standard called RECIST v1.1, which is a way to measure how tumors respond to treatment.
  • Must have adequate function of organs and bone marrow, meaning the organs and bone marrow are working well enough to participate in the study.

Who cannot join the trial?

4 criteria

  • Patients with a type of colorectal cancer that is not **KRAS/NRAS and BRAF Wildtype**. This means the cancer has specific genetic characteristics that are not suitable for the study.
  • Patients whose cancer is not **recurrent**, meaning it has not come back after treatment.
  • Patients whose cancer is not **unresectable**, meaning it can be removed by surgery.
  • Patients whose cancer is not **metastatic**, meaning it has not spread to other parts of the body.
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Investigated drugs

  • Amivantamab

    is a medication used in this trial to treat colorectal cancer. It works by targeting specific proteins on cancer cells, helping to slow down or stop their growth.

  • FOLFIRI

    is a combination of chemotherapy drugs used to treat colorectal cancer. It includes three medications: folinic acid, fluorouracil, and irinotecan. These drugs work together to kill cancer cells or stop them from growing and dividing.

  • Cetuximab

    is a medication that targets a specific protein on the surface of cancer cells. It helps to slow down or stop the growth of cancer cells in colorectal cancer.

  • Bevacizumab

    is a medication that works by blocking the blood supply to tumors. This can help to slow down the growth of cancer cells in colorectal cancer.

What is already known about the treatment

  • Amivantamab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating certain types of colorectal cancer. It is specifically being tested for use in patients with KRAS/NRAS and BRAF wildtype recurrent, unresectable, or metastatic colorectal cancer. Amivantamab works by targeting specific proteins on cancer cells, helping to inhibit their growth and spread. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

  • Cetuximab

    Administered intravenously, cetuximab is an established medication used in the treatment of colorectal cancer, particularly in cases where the cancer is KRAS/NRAS and BRAF wildtype. It is used in combination with other chemotherapy drugs like FOLFIRI. Cetuximab works by blocking the epidermal growth factor receptor (EGFR) on cancer cells, which helps to slow down or stop their growth. It is classified as a monoclonal antibody.

  • Bevacizumab

    This medication is also given intravenously and is used in the treatment of various cancers, including colorectal cancer. It is often used in combination with chemotherapy regimens such as FOLFIRI. Bevacizumab works by inhibiting the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. It is classified as an angiogenesis 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 if not detected early. 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 may become more advanced.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513853-66-00Protocol code61186372COR3002Estimated enrolment700 patientsSponsorJanssen - Cilag International

sourced from the EU Clinical Trials Register and site verification

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