All studies
CompletedPhase IIInterventional

A study to test the effectiveness of a vaccine targeting a protein that hides cancer cells from the body's immune system in operable colorectal cancer that has defective mismatch repair

This study is looking into a new vaccine for a particular type of bowel cancer that can be removed by surgery. This specific type of cancer has certain genetic changes (called 'defective mismatch repair' or MSI-high), which means existing immune-boosting treatments often work well. The vaccine's goal is to stimulate your body's immune system to attack cancer cells. Participants will receive three vaccine doses before their usual surgery. Researchers will then check how much the cancer has shrunk and look for clues in blood, stool, and tumour samples about why the treatment works for some and not others. The study hopes to improve treatments for this kind of bowel cancer.

At a glance

Status
Completed
Phase
Phase II
Sponsor
University of Southampton
Enrolment target
44
Start
31 Aug 2024
Estimated completion
01 Apr 2026

What is this study about?

This study is exploring a new way to treat a specific type of bowel cancer (colon and high rectum cancer) before surgery. Usually, early bowel cancer is treated with surgery, and sometimes chemotherapy for those at higher risk. However, for many, the cancer can return. We need better treatments, and this study focuses on understanding more about the cancer itself.

About 15% of people with early bowel cancer have something called 'defective mismatch repair' (or MSI-high). This means their cancer cells have more genetic mistakes than normal. This is important because newer medicines that help your immune system fight cancer tend to work very well in these cases, sometimes even making the cancer disappear completely. The new vaccine in this study is designed to 'wake up' your immune system to specifically target and fight this kind of bowel cancer.

The main aim is to give the vaccine before your surgery. After surgery, doctors will examine the removed cancer tissue to see how much the vaccine has helped shrink or kill the cancer cells. Researchers will also study blood, stool, and tumour samples to understand why some people respond well to the treatment and others don't. If this study is successful, it could lead to larger studies and potentially new treatments for people with this type of bowel cancer.

Key takeaways

  • This study explores a new vaccine for a specific type of bowel cancer (MSI-high).
  • The vaccine aims to boost your immune system to fight cancer before surgery.
  • If eligible, you'll receive three vaccine doses before your operation.
  • Researchers will study vaccine effects on your tumour and overall health.
  • The study runs from July 2024 to June 2026, with participants followed for at least two years.
  • It could lead to better treatments for this particular bowel cancer.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, diagnosed with bowel cancer (adenocarcinoma of the colon or high rectum). Your cancer must be at a stage where it can be removed by surgery and must not have spread to other parts of your body.

Crucially, your cancer must have a specific genetic feature called 'defective mismatch repair' or 'MSI-high.' This is a special characteristic of the cancer cells that makes them more likely to respond to immune-boosting treatments. You also shouldn't have had any other treatment for your bowel cancer yet before joining.

There will be some blood tests to check your general health, like your blood counts and how well your liver and kidneys are working, to make sure you're well enough for the study. If you're a woman who could become pregnant, you'll need to confirm you're not pregnant and agree to use effective contraception during the study.

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.

  1. Are you 18 years old or older?
  2. Do you have bowel cancer (adenocarcinoma of the colon or high rectum)?
  3. Has your doctor confirmed your cancer can be removed by surgery?
  4. Do you know if your cancer has 'defective mismatch repair' or is 'MSI-high'?
  5. Have you not yet received any treatment for your bowel cancer?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive three doses of the vaccine. Each dose will be given two weeks apart. These vaccinations will happen before you have your standard surgery to remove the cancer. Throughout this vaccination period, and for up to an hour after each injection, you will be carefully watched by the study team.

After your surgery, you might still need standard chemotherapy if any cancer cells are found to have remained. You will be monitored regularly through blood tests, physical examinations, and scans (like CT scans) during the vaccine period and after your surgery. The study team will follow your health for at least two years from the date of your surgery to see how you are doing in the long term.

Potential risks and benefits

One potential benefit of taking part is that the vaccine might activate your immune system to fight and destroy cancer cells in your tumour. This could potentially improve your treatment outcomes. However, like all treatments, there are possible risks. You might experience some swelling or redness around the injection site where you receive the vaccine. The study team will monitor you closely during and after the vaccine injections and will treat any reactions locally. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • -
    Approximate
    -, England

Common questions

What kind of cancer is this study for?

This study is for a specific type of bowel cancer (colon and high rectum) that can be removed with surgery and has particular genetic changes (called 'MSI-high').

What does the vaccine do?

The vaccine is designed to help your body's own immune system recognise and attack this specific type of bowel cancer.

Will I still have surgery?

Yes, you will still have your standard surgery to remove the cancer after getting the vaccine doses.

How long will I be involved in the study?

You'll receive vaccine doses before surgery, and then your health will be followed for at least two years after your surgery.

Where is the study taking place?

The study is being run from the Royal Surrey County Hospital in the UK.

How to find out more

Tony Dhillon

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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