RecruitingOBSERVATIONAL

Prospective National Cohort Evaluating Predictive Biomarkers of Resistance to Immunotherapy in Patients With MSI/dMMR Metastatic Colorectal Cancer (CORESIM)

This study is about advanced bowel cancer that has spread to other parts of the body. Some people with this type of cancer have a specific tumour feature called MSI or dMMR, which means they can be treated with a type of medicine called immunotherapy, like pembrolizumab. While immunotherapy works well for many, it doesn't work for everyone. About 2 to 3 out of every 10 patients don't respond to it. Researchers want to understand why this happens. They are collecting information and tumour samples from patients across France to look for signs (called biomarkers) that might predict whether immunotherapy will be effective. The goal is to help doctors pick the best treatment for each person, ensuring more patients receive the most helpful medicine for their cancer.

At a glance

Status

Recruiting

Sponsor

Federation Francophone de Cancerologie Digestive

Enrolment target

600

Start

12 Feb 2024

Estimated completion

12 Feb 2030

Colorectal Cancer Metastatic Microsatellite Instability-High Colorectal Cancer

What is this study about?

This study focuses on people with advanced bowel cancer that has spread to other parts of their body, known as metastatic colorectal cancer. Specifically, it's for those whose cancer has a particular genetic feature called MSI or dMMR. This feature means their cancer is more likely to respond to a type of treatment called immunotherapy.

Immunotherapy, like the drug pembrolizumab, works by helping your own immune system fight the cancer. For many patients, this treatment can be very effective. However, doctors have noticed that for about 20-30% of patients, this immunotherapy doesn't work as well as expected, even if their cancer has the MSI/dMMR feature. This study wants to find out why.

Researchers are gathering information and samples from patients treated with pembrolizumab across France. They will look closely at these samples to find specific indicators, or "biomarkers," that might show who will respond well to immunotherapy and who might not. By identifying these biomarkers, doctors could one day predict which patients will benefit most from immunotherapy and which might need a different treatment approach from the start, saving valuable time and ensuring everyone gets the most suitable care.

Key takeaways

This study aims to improve bowel cancer treatment by understanding why immunotherapy doesn't work for everyone.
It focuses on advanced bowel cancer with specific features called MSI-H or dMMR.
Researchers will look at samples and medical records to find clues (biomarkers) that predict treatment response.
Your regular medical care will not change if you participate.
Your contribution could help future patients receive more effective, personalised treatments.
Participation involves sharing medical data, usually with no additional appointments.

Who may be eligible?

To be part of this study, you would need to be over 18 years old and have bowel cancer that has spread and cannot be removed by surgery. Your cancer must have the specific genetic feature known as MSI-H or dMMR, which doctors check for using special tests on your tumour.

The study is for people who are receiving pembrolizumab immunotherapy as their very first treatment for this type of advanced bowel cancer.

There are also some reasons why you might not be able to join. For example, if you have another serious cancer that needs treatment, if you've already had immunotherapy or chemotherapy for your advanced bowel cancer, or if you are pregnant. The study also cannot include individuals who might find it difficult to attend follow-up appointments due to other cognitive or social reasons.

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 over 18 years old?
Do you have advanced bowel cancer that has spread?
Has your doctor confirmed your cancer has the MSI-H or dMMR feature?
Are you about to start or have you recently started pembrolizumab as your first treatment for this advanced cancer?
Have you not had immunotherapy or chemotherapy for this advanced bowel cancer before?
Are you able to attend your regular hospital follow-ups?

Answer every question to see your result.

What does participation involve?

If you join this study, your regular medical care will stay the same as you receive pembrolizumab for your bowel cancer. The researchers will collect information about your treatment and your health journey from your medical records. For some patients, they will also collect samples (like stored tissue biopsies or blood samples) that were taken as part of your routine care.

This study is looking back at some patients' treatments since February 2021 and will also include new patients starting treatment from February 2024. All patients who take part will be followed for three years to see how they are doing. This follow-up will mainly involve checking your existing medical records and test results, so you likely won't need extra hospital visits just for the study.

Potential risks and benefits

Taking part in this study primarily involves sharing your medical information, so it adds very few direct risks to your usual care. The main benefit is that your contribution will help doctors better understand bowel cancer and improve treatment decisions for future patients. This research could lead to more personalised and effective treatments. It's important to remember you can choose to stop participating in the study at any time, without it affecting your medical care.

Locations (20)

Ch - Centre Hospitalier de La Côte Basque
Verified postcode
Bayonne, France· Not yet recruiting
Ch - Ch Beauvais
Verified postcode
Beauvais, France· Not yet recruiting
CH Jean Minjoz
Verified postcode
Besançon, France· Not yet recruiting
Polyclinique Saint Privat
Verified postcode
Boujan-sur-Libron, France· Recruiting
Ch - Duchenne
Verified postcode
Boulogne-sur-Mer, France· Not yet recruiting
Ch - Centre Hospitalier Metropole Savoie
Verified postcode
Chambéry, France· Not yet recruiting
Ch - Centre Hospitalier de Cholet
Verified postcode
Cholet, France· Not yet recruiting
CH - Compiegne
Verified postcode
Compiègne, France· Not yet recruiting
Ch - Chd Vendée
Verified postcode
La Roche-sur-Yon, France· Not yet recruiting
CH - Louis Pasteur
Verified postcode
Le Coudray, France· Not yet recruiting
Centre Hospitalier Regional et Universitaire de Lille
Verified postcode
Lille, France· Recruiting
CH Saint Joseph - Saint Luc
Verified postcode
Lyon, France· Not yet recruiting

Common questions

What is MSI/dMMR?

MSI/dMMR are features in your cancer cells that mean they might respond better to certain treatments like immunotherapy. Doctors check for these features with special tests.

What is immunotherapy (pembrolizumab)?

Pembrolizumab is a type of medicine that helps your body's own immune system find and fight cancer cells more effectively.

Will I have extra doctor visits if I join?

No, this study mainly collects information from your existing medical records and samples taken during your routine care, so you shouldn't need extra visits just for the study.

How long will I be involved in the study?

Patients are followed for three years after starting their treatment, with information gathered from their medical records.

What will happen to my personal information?

Your medical information will be used for research purposes, but your name and identifying details will be removed to protect your privacy.

How to find out more

Aziz ZAANAN, MD, PhD

aziz.zaanan@aphp.fr 03 80 66 80 13 Official trial record

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