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 study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hopital Saint Antoine	Paris	France
Ikzrxrtc Rbqwkber Dv Cqinzc Df Mnkrnidhjmz	Montpellier	France
Bzkueuqw Ungyjrjphx Hvvmzywy Csicsr	Besançon	France
Hibsyduc Vphl dtdrjnlj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.03.2023
Spain	Not recruiting	01.03.2023

Trial locations

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.

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 ID:

2023-509509-62-00

Protocol code:

EOCRC2-22

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on EO4010 Vaccine with Nivolumab and Bevacizumab for Patients with Metastatic Colorectal Cancer Who Have Already Received Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?