A global multicenter phase 1/2 trial of EO4010, a novel microbial-derived peptide therapeutic vaccine, in combination with nivolumab and/or bevacizumab, for treatment of patients with previously treated metastatic colorectal carcinoma (the "AUDREY" study).
The "AUDREY" study is looking for adults with advanced bowel cancer that has spread to other parts of the body and has already been treated. This study is testing a new type of treatment, a vaccine called EO4010, along with other common cancer medicines like nivolumab (Opdivo) and/or bevacizumab (Zirabev). The main aim is to understand if this new vaccine combination is safe and what side effects it might cause. Researchers will also look at how well the new treatment works and if it helps people live longer or keeps the cancer from growing. This is an early-stage study, meaning it's one of the first times this vaccine is being given to people.
At a glance
What is this study about?
This study, known as the "AUDREY" study, is designed for people who have advanced bowel cancer that has spread to other parts of their body (metastatic) and has already received some treatment. The main goal of this research is to test a new medicine, which is a vaccine called EO4010. This vaccine is made from tiny parts of germs (microbes) and is thought to help your body's immune system fight cancer cells.
In this study, the new vaccine EO4010 will be given alongside other medicines that are already used to treat cancer. These include nivolumab (brand name Opdivo), which is an immunotherapy that helps your immune system, and bevacizumab (brand name Zirabev), which works by stopping blood vessels from growing into the tumour. Researchers want to see if combining these treatments is safe and if it can improve how well bowel cancer is treated.
The study will look very closely at the safety of these combined treatments, checking for any side effects and how people feel. They will also measure how the treatments affect the cancer itself, such as whether it shrinks or stops growing, and ultimately, if it can help people live longer and have a better quality of life. This is an important step in finding new and better ways to treat advanced bowel cancer.
Key takeaways
- This study (AUDREY) is for adults with advanced, previously-treated bowel cancer.
- It tests a new vaccine (EO4010) with existing cancer drugs (Opdivo/Zirabev).
- The main focus is to check the safety and side effects of the new combination.
- Researchers will also see if the new treatment helps control the cancer.
- Participation involves regular hospital visits, tests, and receiving study medicines.
- You can stop participating at any time without affecting your care.
Who may be eligible?
This study is for adults, aged 18 and over, of any gender. You would be considered if you have bowel cancer that has spread to other parts of your body and cannot be removed by surgery.
Crucially, you must have already received some treatment for your advanced bowel cancer. This study is not for people who are, for example, just starting their first treatment for advanced bowel cancer.
There will be other detailed medical checks to make sure this study is right for you and safe for your current health condition. Your doctor or the study team will go through all the specific requirements with you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with bowel cancer that has spread to other parts of your body?
- Has your bowel cancer already been treated before (e.g., with chemotherapy)?
- Is your cancer not suitable for surgery to remove it?
- Are you able to attend regular hospital appointments?
What does participation involve?
If you decide to take part in this study, you'll have regular hospital visits for check-ups, blood tests, and to receive the study medicines (EO4010, nivolumab, and/or bevacizumab) through a drip. The number and frequency of visits will depend on the specific stage of the study you are in and will be explained fully by the study team.
You will have several tests, including scans to measure your cancer and blood samples to check your general health and how your immune system is responding to the vaccine. There will also be careful monitoring for any side effects you might experience.
The total duration of your participation could vary, but it would involve ongoing treatment and follow-up appointments for a significant period, potentially several months or longer. The exact schedule will be clearly outlined to you before you agree to participate.
Potential risks and benefits
Locations (2)
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Common questions
What is EO4010?
EO4010 is a new experimental vaccine made from parts of germs. It's designed to help your body's own immune system fight cancer cells.
What does 'metastatic colorectal carcinoma' mean?
It means bowel cancer that has spread from where it started to other parts of your body. 'Previously treated' means you've already had some treatment for it.
Are nivolumab and bevacizumab new drugs?
No, these are existing cancer medicines (Opdivo and Zirabev, respectively) that are already used in clinics. This study is looking at combining them with the new vaccine.
Why is this called a 'Phase 1/2' study?
This means it's an early-stage study. Phase 1 mainly checks if the new treatment is safe and what dose to use, while Phase 2 starts to look at how well it works.
Will I know if I'm getting the new vaccine?
All participants in this study will receive the experimental vaccine EO4010 in combination with one or both of the other medicines. There isn't a placebo group in this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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