Active not recruitingPHASE2INTERVENTIONAL

Immunotherapy in MSI/dMMR Tumors in Perioperative Setting.

This research study is investigating an immunotherapy drug called pembrolizumab for patients with certain cancers that can be removed by surgery. The study specifically includes cancers that have a particular genetic feature known as MSI/dMMR. Researchers want to find out if giving pembrolizumab before surgery is safe and helps shrink these tumors, potentially making surgery more effective or improving long-term outcomes. The hope is that this treatment could lead to better results for patients with these specific types of cancer, no matter where in the body they are. The study is run over multiple medical centres and will involve different types of cancer, mainly colon, rectal, and oesophagogastric cancers, but other types with the same genetic features may also be included.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Centre Leon Berard

Enrolment target

240

Start

18 Oct 2021

Estimated completion

01 Oct 2029

Localized Resectable Tumor MSI/dMMR

What is this study about?

This research study is looking into a new treatment approach for certain types of cancer before surgery. The study focuses on cancers that have a specific genetic fingerprint called "MSI/dMMR." This means the cancer cells have a problem with their DNA repair system, which can sometimes make them more responsive to certain treatments, including immunotherapy.

The main aim is to see if an immunotherapy drug called pembrolizumab, given before surgery, can help shrink these tumors. Immunotherapy works by boosting your body's own immune system to fight cancer cells. Researchers believe that giving this treatment early, before surgery, might significantly improve how well patients respond and could even lead to a complete disappearance of cancer cells in some cases, which could lead to better long-term survival.

While the study is particularly interested in colon, rectal, and stomach cancers due to how common they are with this genetic feature, it's open to people with other types of localized MSI/dMMR cancers too. By studying these cancers across different locations, the researchers hope to understand if this treatment method could benefit a wider range of patients.

Key takeaways

This study uses an immunotherapy drug (pembrolizumab) before surgery.
It's for specific cancers with a genetic feature called MSI/dMMR.
The goal is to see if this improves treatment results and survival.
You'll receive treatment over 6 weeks, followed by surgery.
Your health and any side effects will be closely monitored.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have a confirmed cancer diagnosis that can be removed by surgery and hasn't spread to other distant parts of your body. Your cancer also needs to have the specific genetic characteristic called MSI/dMMR.

The types of cancer included are colon or rectal cancer, oesophagus or stomach cancer, or certain small bowel cancers (in the duodenum, jejunum, or ileum).

Doctors will also check your overall health and how well your vital organs (like your liver, kidneys, and blood) are working to make sure it's safe for you to take part.

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?
Do you have a cancer that can be surgically removed and hasn't spread widely?
Has your cancer been tested and confirmed to have the MSI/dMMR feature?
Is your overall health good enough for treatment, as assessed by your doctor?
Are you able to attend all scheduled hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive the study drug, pembrolizumab, through a drip into your arm (intravenously) over 30 minutes. You'll have up to four doses, typically given over 6 weeks before your planned surgery. These treatments will be scheduled as part of your regular hospital visits.

Your surgery will then take place about 6 weeks after your last pembrolizumab treatment, following normal hospital procedures. After surgery, your doctors will decide if you need any further treatment, depending on how you responded to the pre-surgery treatment and your overall health.

Throughout the study, your health will be carefully monitored. Information about your treatment and any side effects will be recorded. This study doesn't have a fixed total duration for each patient, as follow-up will depend on your individual treatment plan and recovery.

Potential risks and benefits

Taking part in this study could offer potential benefits by giving you access to a new treatment that might improve the outcome of your cancer. It's hoped that giving pembrolizumab before surgery could shrink your tumor more effectively and potentially improve your long-term health. However, like all medications, pembrolizumab can have side effects, which your doctor will discuss with you. You might also experience discomfort from scans, blood tests, and hospital visits. The study team will closely monitor you to ensure your safety. Remember, participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your standard care.

Locations (18)

CHU Amiens Picardie
Verified postcode
Amiens, France
CHU Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France
Centre Georges-Francois Leclerc
Verified postcode
Dijon, France
Hopital Huriez
Verified postcode
Lille, France
Centre Léon Bérard
Verified postcode
Lyon, France
Institut Paoli Calmettes
Verified postcode
Marseille, France
Institut du Cancer Val d'Aurelle
Verified postcode
Montpellier, France
Centre Antoine Lacassagne
Verified postcode
Nice, France
APHP Hôpital Saint-Louis
Verified postcode
Paris, France
Institut mutualiste Montsouris
Verified postcode
Paris, France
Hôpital Européen Georges Pompidou
Verified postcode
Paris, France
APHP - Hôpital Saint-Antoine
Verified postcode
Paris, France

Common questions

What is MSI/dMMR?

MSI/dMMR refers to a specific genetic feature in cancer cells where there's a problem with their natural repair system for DNA. This can make them suitable for certain treatments.

What is pembrolizumab?

Pembrolizumab is an immunotherapy drug that works by helping your body's own immune system recognise and fight cancer cells more effectively.

Will I still need surgery?

Yes, surgery is still a planned part of your treatment. The pembrolizumab is given before surgery to try and improve its effectiveness.

How long will I be on the study treatment for?

You will receive up to four doses of pembrolizumab, usually over 6 weeks, before your surgery.

Are there other treatment options available?

Yes, your doctor can discuss all available standard treatment options for your type of cancer, alongside this study.