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Study on Avelumab and Cetuximab for Patients with Metastatic Colorectal Cancer Who Have Previously Received Treatment

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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 the effects of a combination treatment for patients with metastatic colorectal cancer, a type of cancer that has spread from the colon or rectum to other parts of the body. The study involves two medications: avelumab and cetuximab. Avelumab is a type of medication known as a human monoclonal antibody, which is a protein designed to help the immune system fight cancer. Cetuximab is another monoclonal antibody that targets specific proteins on cancer cells to stop their growth.

The purpose of this study is to evaluate how effective the combination of avelumab and cetuximab is compared to using cetuximab alone in patients who have already received treatment for their cancer. Participants in the study will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will last for a period of up to 12 months, during which the participants' health and response to the treatment will be closely monitored.

Throughout the study, researchers will assess various outcomes, including the overall survival time, which is the length of time patients live after starting the treatment. They will also look at how many patients experience a reduction in cancer size and how long patients live without the cancer getting worse. Safety will be monitored by checking for any side effects and conducting regular health assessments. This study aims to provide valuable information on whether the combination of avelumab and cetuximab can offer better outcomes for patients with metastatic colorectal cancer.

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

    Enrollment

    Upon joining the study, the patient is enrolled after meeting specific criteria, including age, health status, and previous treatment history.

    The patient must have a confirmed diagnosis of metastatic colorectal cancer and meet other health-related criteria.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of two groups: one receiving a combination of avelumab and cetuximab, and the other receiving cetuximab alone.

    This process ensures that the study results are unbiased and scientifically valid.

  3. Step 3

    Treatment administration

    The patient receives the assigned treatment through an IV infusion.

    The dosage and frequency of administration are determined by the study protocol and the patient's health status.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient's health is closely monitored through regular assessments, including clinical laboratory tests, vital signs, and electrocardiograms (ECGs).

    The patient's response to the treatment is evaluated using specific criteria to determine any changes in the disease.

  5. Step 5

    Follow-up

    After completing the treatment phase, the patient enters a follow-up period where their health and any long-term effects of the treatment are monitored.

    This phase helps gather data on the overall survival and progression-free survival of the patient.

Who can join the trial?

15 criteria

  • Sign a written informed consent form before any trial-related procedures that are not part of standard care.
  • Have an ECOG PS of 0 to 1 at trial entry. ECOG PS stands for Eastern Cooperative Oncology Group Performance Status, which measures how well you can perform daily activities.
  • Have an estimated life expectancy of more than 12 weeks.
  • Have adequate blood function, which means having certain levels of white blood cells, neutrophils, lymphocytes, platelets, and hemoglobin.
  • Have adequate liver function, which means having certain levels of bilirubin, AST, and ALT. These are substances measured in the blood to check liver health.
  • Have adequate kidney function, which means having a creatinine clearance greater than 30 mL/min. This measures how well your kidneys are working.
  • Use effective contraception if there is a risk of pregnancy, for both men and women, during the study and for at least 2 months after the last treatment. This is important because the effects of the trial drug on an unborn baby are unknown.
  • Be 18 years of age or older.
  • Have a confirmed diagnosis of colorectal adenocarcinoma, which is a type of cancer that starts in the colon or rectum.
  • Have a diagnosis of metastatic disease, meaning the cancer has spread to other parts of the body.
  • Have RAS and BRAF wild-type status in a liquid biopsy at initial diagnosis. This means certain genes in the cancer cells do not have specific mutations.
  • Have shown a major response to a first-line therapy containing an anti-EGFR drug. This means the cancer significantly shrank or disappeared with the first treatment.
  • Have received a second-line therapy.
  • Have more than 4 months since the last dose of an anti-EGFR drug given in the first-line treatment before joining the study.
  • Have measurable disease according to RECIST criteria v1.1. This means the cancer can be measured in size using specific guidelines.

Who cannot join the trial?

6 criteria

  • Patients with a different type of cancer other than colorectal metastatic cancer cannot participate. This means the cancer must have started in the colon or rectum and spread to other parts of the body.
  • Patients who have not been previously treated for their cancer are not eligible. This study is for those who have already received treatment.
  • Patients with genetic mutations in the RAS or BRAF genes are excluded. These are specific genes that can affect how cancer grows.
  • Patients who are not within the specified age range cannot participate. The study is open to adults only.
  • Both male and female patients are eligible, but those who are pregnant or breastfeeding may be excluded for safety reasons.
  • Patients who are part of a vulnerable population, such as those unable to give informed consent, are not eligible.
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Investigated drugs

  • Avelumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, it is being used to see if it can improve survival in patients with a specific type of colorectal cancer.

  • Cetuximab

    is a targeted therapy that works by blocking a protein on the surface of cancer cells, which can slow down or stop their growth. It is used in this trial both alone and in combination with avelumab to determine if the combination is more effective than cetuximab alone in treating colorectal cancer.

What is already known about the treatment

  • Avelumab

    Avelumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently being studied in clinical trials for its effectiveness in treating metastatic colorectal cancer, particularly in patients with specific genetic profiles. Avelumab works by targeting and blocking a protein called PD-L1, which helps cancer cells evade the immune system. This action allows the immune system to better recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Cetuximab

    Cetuximab is also administered as an intravenous infusion, usually in a healthcare facility. It is an established treatment for certain types of cancer, including metastatic colorectal cancer, and is being further studied in combination with other drugs like avelumab. Cetuximab works by binding to the epidermal growth factor receptor (EGFR) on the surface of cancer cells, blocking signals that promote cancer cell growth and survival. It is classified as a monoclonal antibody targeting EGFR.

Investigated diseases

Colorectal Metastatic Cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It often progresses through stages, starting in the lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs, such as the liver or lungs. The spread of cancer cells to other parts of the body is known as metastasis. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. As the disease advances, it can lead to more severe symptoms and complications. The progression and impact of the disease can vary based on the location and extent of the spread.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519481-44-00Protocol codeCAVE-2Estimated enrolment173 patientsSponsorGruppo Oncologico Dell'Italia Meridionale

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).