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Study on EO4010 Vaccine with Nivolumab and Bevacizumab for Patients with Metastatic Colorectal Cancer Who Have Already 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 a treatment for patients with metastatic colorectal cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study will explore the effects of a new treatment called EO4010, which is a vaccine designed to help the immune system fight cancer. This vaccine will be tested in combination with two other medications: nivolumab (also known by its code name BMS936558) and bevacizumab. Nivolumab is an immune checkpoint blocker, a type of drug that helps the immune system recognize and attack cancer cells. Bevacizumab is a medication that works by preventing the growth of blood vessels that supply nutrients to tumors, thereby inhibiting their growth.

The purpose of this study is to evaluate the safety and tolerability of EO4010 when used with nivolumab and/or bevacizumab in patients who have already received treatment for their cancer. Participants in the study will receive these treatments and will be monitored for any side effects or adverse reactions. The study will also look at how the immune system responds to the vaccine by measuring the presence of specific immune cells in the blood. This will help researchers understand if the vaccine is effective in stimulating the immune system to fight the cancer.

Throughout the study, participants will receive regular check-ups and assessments to monitor their health and the progress of their cancer. The study aims to provide valuable information on the potential benefits and risks of using EO4010 in combination with nivolumab and bevacizumab for treating metastatic colorectal cancer. The findings from this study could lead to new treatment options for patients with this type of cancer in the future.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of metastatic colorectal carcinoma and ensuring previous treatments have been administered.

    Eligibility criteria include being HLA-A2 positive, having a specific type of colorectal cancer, and meeting certain health status requirements.

  2. Step 2

    Treatment phase 1

    The first phase of treatment involves the administration of EO4010, a novel cancer vaccine. This is given as a subcutaneous injection, which means it is injected under the skin.

    The frequency and dosage of EO4010 are determined by the study protocol and are monitored closely for safety and tolerability.

  3. Step 3

    Treatment phase 2

    In the second phase, nivolumab is introduced. This medication is administered intravenously, meaning it is given through a vein.

    The dosage is 10 mg/mL, and it is provided as a solution for infusion. The frequency and duration are specified by the study protocol.

  4. Step 4

    Treatment phase 3

    The third phase includes the addition of bevacizumab, also administered intravenously.

    The dosage is 25 mg/mL, and it is given as a solution for infusion. The schedule is determined by the study protocol.

  5. Step 5

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess safety and tolerability. This includes tracking any adverse events or side effects.

    The effectiveness of the treatment is evaluated by measuring the immune response and other clinical outcomes.

  6. Step 6

    Completion and follow-up

    Upon completion of the treatment phases, a final assessment is conducted to evaluate the overall response to the therapy.

    Follow-up visits may be scheduled to monitor long-term effects and gather additional data.

Who can join the trial?

9 criteria

  • Patients must have **unresectable** colorectal cancer. This means the cancer cannot be removed with surgery.
  • The cancer should be **locally advanced** or **metastatic**, meaning it has spread to nearby areas or other parts of the body.
  • Patients must have been previously treated with standard therapies or are not suitable for them. These therapies include certain types of chemotherapy and targeted treatments.
  • The cancer must be **mismatch repair proficient** and **microsatellite stable**, which are specific characteristics of the cancer cells.
  • Patients must be **HLA-A2 positive**, which is a specific genetic marker.
  • The cancer must have progressed during or within 3 months after the last standard treatment.
  • Patients must be **18 years or older**.
  • Patients must have an **ECOG performance status** of 0 to 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Both **male and female** patients can participate.

Who cannot join the trial?

6 criteria

  • Patients who have not been previously treated for their colorectal cancer.
  • Patients whose cancer can be surgically removed.
  • Patients who do not have locally advanced or metastatic colorectal cancer. Locally advanced means the cancer has spread to nearby areas, and metastatic means it has spread to other parts of the body.
  • Patients who are not within the specified age range for the trial.
  • Patients who are not able to safely participate in the trial due to other health conditions.
  • Patients who are part of a vulnerable population that requires special protection.
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Investigated drugs

  • EO4010

    is a new type of vaccine made from microbial peptides. It is being tested to see if it is safe and can be tolerated by patients. This vaccine is designed to help the immune system recognize and fight cancer cells in patients with metastatic colorectal carcinoma.

  • Nivolumab

    is a medication that helps the immune system attack cancer cells. It works by blocking a protein that stops the immune system from working properly, allowing it to better target and destroy cancer cells.

  • Bevacizumab

    is a medication that helps prevent the growth of new blood vessels that tumors need to grow. By blocking these blood vessels, it can help slow down or stop the growth of cancer.

What is already known about the treatment

  • EO4010

    This medication is administered as an injection and is currently being studied in clinical trials for its safety and effectiveness. It is being tested for use in patients with advanced colorectal cancer that cannot be surgically removed and has already been treated with other therapies. EO4010 is a peptide vaccine derived from microbes, designed to stimulate the immune system to target cancer cells. It falls under the category of therapeutic vaccines, aiming to enhance the body's natural defenses against cancer.

  • Nivolumab

    This medication is given as an intravenous infusion and is widely used in medicine, with extensive documentation in medical literature. It is primarily used to treat various types of cancer, including colorectal cancer. Nivolumab works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy.

  • Bevacizumab

    Administered through an intravenous infusion, this medication is well-established in medical practice and literature. It is used to treat several types of cancer, including colorectal cancer. Bevacizumab works by inhibiting a protein called VEGF, which is responsible for the growth of new blood vessels that tumors need to grow. It is classified as an angiogenesis inhibitor, a type of targeted therapy.

Investigated diseases

Colorectal Carcinoma – Colorectal carcinoma is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, benign clumps of cells called polyps that can develop into cancer over time. As the disease progresses, it can invade deeper layers of the colon or rectum and spread to nearby lymph nodes or other organs, such as the liver or lungs. Symptoms may include changes in bowel habits, blood in the stool, abdominal discomfort, and unexplained weight loss. The disease is classified as locally advanced when it has spread to nearby tissues but not distant organs, and metastatic when it has spread to distant parts of the body. Treatment options vary depending on the stage and location of the cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-509509-62-00Protocol codeEOCRC2-22Estimated enrolment42 patientsSponsorEnterome

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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).