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RecruitingPHASE3INTERVENTIONAL

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

This research is investigating a new medication called dostarlimab for people in the UK who have a specific type of colon cancer that hasn't spread to other parts of the body. This particular cancer has certain features (dMMR/MSI-H) that mean it might respond well to immune-boosting treatments. The study aims to find out if using dostarlimab around the time of surgery (before and/or after) is more effective than current standard treatments like chemotherapy (CAPEOX or FOLFOX) in preventing the cancer from coming back or improving long-term outcomes. Participants will be closely monitored, and their progress will be compared to see which approach works best for this specific colon cancer type.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
GlaxoSmithKline
Enrolment target
892
Start
01 Aug 2023
Estimated completion
27 Mar 2031

What is this study about?

This study is about a type of bowel cancer (colon cancer) that hasn't spread to other parts of the body. Doctors are looking for better ways to treat this specific kind of cancer to improve patients' chances of recovery. They are particularly interested in cancers that have certain genetic features, called dMMR or MSI-H. These features suggest the cancer might respond well to treatments that help your body's immune system fight the cancer.

The main aim of this study is to compare a new drug, called dostarlimab, with the usual treatments currently given. Dostarlimab is a type of immunotherapy, which means it works by boosting your body's own immune system to recognise and attack cancer cells. The study wants to see if giving dostarlimab around the time of surgery (either before, after, or both) works better than the standard chemotherapy treatments like CAPEOX or FOLFOX. 'Perioperative' simply means 'around the time of surgery'.

By taking part, you would be helping doctors understand if this new approach can lead to better outcomes for patients with this specific type of colon cancer. This could include reducing the chance of the cancer coming back or improving overall health after treatment. It's an important step in finding more effective and gentle treatments for cancer.

Key takeaways

  • The study compares a new immune-boosting drug (dostarlimab) with standard chemotherapy for colon cancer.
  • It's for a specific type of colon cancer that hasn't spread and has certain genetic features.
  • Treatment is given around the time of surgery (before and/or after).
  • Participation involves regular clinic visits for treatment and monitoring.
  • You might receive the new drug or one of the standard treatments.
  • The goal is to find better ways to treat this type of colon cancer.

Who may be eligible?

To join this study, you need to have colon cancer that has been diagnosed recently and hasn't yet been treated. The cancer must be a specific type that doctors call 'T4N0' or 'Stage III', which means it's still contained in the colon and hasn't spread to distant parts of your body. Importantly, your cancer must have a special genetic marker called dMMR or MSI-H, which the doctors will check for. You also need to be at least 18 years old.

There are several reasons why you might not be able to join. For example, if your cancer has already spread to other organs (like your liver or lungs), or if you've already had treatment for this cancer (like chemotherapy, radiation, or certain surgeries). You also can't join if the cancer is causing a severe blockage that needs immediate surgery, or if you've recently had a major operation. Conditions like certain lung problems (interstitial lung disease, pneumonitis), severe liver disease, or a history of organ transplants would also prevent you from joining. If you are pregnant, breastfeeding, or planning to become pregnant, you cannot take part.

Quick self-check
  • Do you have a recent diagnosis of colon cancer that hasn't been treated yet?
  • Has your doctor confirmed your colon cancer is 'T4N0' or 'Stage III'?
  • Has your cancer been tested for 'dMMR' or 'MSI-H' markers and found to have them?
  • Are you at least 18 years old?
  • Has your cancer NOT spread to other parts of your body?
  • Have you NOT had previous chemotherapy, radiation, or recent major surgery for this cancer?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive either the new drug (dostarlimab) or a standard chemotherapy treatment (CAPEOX or FOLFOX), usually given before or after your surgery for colon cancer. The specific schedule and number of treatments would be explained in detail by the study team. You would need to attend regular appointments at the clinic for treatment, blood tests, and check-ups to monitor your health and how the treatment is working. This will likely involve scans and other tests. The exact number of visits and the full duration of your participation would depend on which treatment group you are in and will be detailed by the study team, but typically, studies like this involve follow-up for several years.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as access to a new treatment (dostarlimab) that isn't yet widely available, and very close monitoring of your health by a specialist medical team. However, there are also potential risks. The new drug may have side effects that are not yet fully understood, and both the new drug and standard treatments can cause side effects. These can range from mild to severe, and the study team will discuss all known potential side effects with you. It's important to remember that you can decide to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (266)

  • GSK Investigational Site
    Tucson, United States· Recruiting
  • GSK Investigational Site
    Los Angeles, United States· Recruiting
  • GSK Investigational Site
    New Haven, United States· Recruiting
  • GSK Investigational Site
    Washington D.C., United States· Withdrawn
  • GSK Investigational Site
    Deerfield Beach, United States· Withdrawn
  • GSK Investigational Site
    Fort Lauderdale, United States· Withdrawn
  • GSK Investigational Site
    Marietta, United States· Withdrawn
  • GSK Investigational Site
    Chicago, United States· Recruiting
  • GSK Investigational Site
    Chicago, United States· Recruiting
  • GSK Investigational Site
    Chicago, United States· Withdrawn
  • GSK Investigational Site
    Naperville, United States· Recruiting
  • GSK Investigational Site
    Naperville, United States· Recruiting

+254 more sites — see the official record for the full list.

Common questions

What is 'dMMR/MSI-H' colon cancer?

This is a specific type of colon cancer that has changes in its genes, making it more likely to respond to certain immune-boosting treatments like dostarlimab.

What is dostarlimab?

Dostarlimab is a new medication that works with your immune system to help it find and fight cancer cells more effectively.

What are CAPEOX and FOLFOX?

These are common types of chemotherapy treatments used for colon cancer. They involve a combination of drugs designed to kill cancer cells.

Will I definitely get the new drug?

This is a comparison study, so you might receive the new drug (dostarlimab) or one of the standard chemotherapy treatments (CAPEOX or FOLFOX). The study team will tell you more about this.

What does 'Phase 3' mean for a study?

Phase 3 means this is a large study comparing a new treatment to existing ones. It's often the final step before a new treatment might become widely available.

How to find out more

US GSK Clinical Trials Call Center

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

Interested in taking part?

Register your interest

Share your details and the research team for "Study of Perioperative Dostarlimab in Participants With Untr…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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