RecruitingPHASE2INTERVENTIONAL

A Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer

This study aims to discover if a new treatment approach is more effective for people with a certain type of colon cancer that hasn't spread. The treatment involves giving a drug called dostarlimab alongside a chemotherapy combination known as CAPEOX, before surgery. Researchers want to see if this combination works better than just CAPEOX alone. The study focuses on people whose cancer cells have normal DNA repair systems. They will also look at blood and tumour markers to better understand how the treatment affects the cancer. This helps scientists learn if dostarlimab improves the treatment's success and could lead to better future care.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

120

Start

18 Feb 2025

Estimated completion

26 Oct 2028

Neoplasms, Colon

What is this study about?

This research study is investigating a new way to treat colon cancer, specifically for people whose cancer has not yet spread to distant parts of their body. The treatment is given *before* any surgery takes place. This is often called 'neoadjuvant therapy'.

The study involves giving two different treatments: a new drug called dostarlimab, and a standard chemotherapy combination known as CAPEOX. CAPEOX is short for 'capecitabine' and 'oxaliplatin', which are both chemotherapy medicines. The main question the researchers want to answer is whether giving dostarlimab *with* CAPEOX works better than giving CAPEOX on its own.

Researchers are particularly interested in a specific type of colon cancer where the cells have normal DNA repair systems. They will also be looking closely at markers in the blood and in the tumour tissue itself. This will help them understand how the treatment is working at a very detailed level and could give them clues about who might benefit most from this new approach.

Key takeaways

This study tests a new two-drug treatment (dostarlimab + CAPEOX) before colon cancer surgery.
It compares this new approach to standard CAPEOX chemotherapy alone.
Participants must have a specific type of colon cancer that hasn't spread.
The goal is to see if the new combination is more effective and how it works.
It's for adults aged 18+ with previously untreated colon cancer suitable for surgery.

Who may be eligible?

This study is for adults aged 18 and over who have colon cancer that has been recently diagnosed and has not yet been treated. Your cancer must be at a stage where it hasn't spread to other distant parts of your body. Doctors will also need to be able to remove your cancer with surgery.

Importantly, your cancer must be a specific type where the cells have normal DNA repair systems. Doctors will check this using special tests on your tumour tissue. You'll need to be fit enough for the study, usually meaning you can carry out most daily activities without too much difficulty. You also shouldn't have certain other serious health problems, especially those related to your immune system or lungs, or have reacted badly to similar treatments in the past.

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 recently been diagnosed with colon cancer that hasn't been treated yet?
Is your colon cancer at a stage where it hasn't spread to distant parts of your body?
Has your doctor confirmed that your cancer can be removed with surgery?
Have tests on your tumour shown that your cancer cells have 'normal DNA repair systems'?
Are you generally well and able to carry out most daily activities without much difficulty?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the CAPEOX chemotherapy combination or dostarlimab plus CAPEOX chemotherapy, all given before your surgery. You will have regular visits to the hospital for your treatment and to have assessments like blood tests and scans. You will also need to provide fresh tumour tissue, usually taken during a colonoscopy, for special tests.

The study will involve taking several medications as part of your treatment. Doctors and nurses will monitor you closely for any side effects or changes in your health. After your initial treatment and surgery, there will be a follow-up period to see how you are doing long-term. The total duration of your participation will vary depending on your treatment plan and follow-up schedule.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than standard care, or you might help researchers learn more about colon cancer, which could help future patients. However, there's no guarantee that the new treatment will work for everyone, and you might experience side effects from the chemotherapy and study drug. These side effects can vary from mild to severe, and the study team will explain all known risks to you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (33)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
Verified postcode
Aalst, Belgium· Recruiting
GSK Investigational Site
Verified postcode
Bonheiden, Belgium· Recruiting
GSK Investigational Site
Verified postcode
Brussels, Belgium· Recruiting
GSK Investigational Site
Verified postcode
Brussels, Belgium· Recruiting
GSK Investigational Site
Verified postcode
Ghent, Belgium· Recruiting
GSK Investigational Site
Verified postcode
Leuven, Belgium· Recruiting
GSK Investigational Site
Verified postcode
Liège, Belgium· Recruiting
GSK Investigational Site
Verified postcode
Liège, Belgium· Recruiting
GSK Investigational Site
Verified postcode
Ostend, Belgium· Recruiting
GSK Investigational Site
Verified postcode
Roeselare, Belgium· Recruiting
GSK Investigational Site
Verified postcode
Turnhout, Belgium· Recruiting
GSK Investigational Site
Verified postcode
Milan, Italy· Recruiting

Common questions

What does 'neoadjuvant' mean?

It means the treatment is given before your main surgery to help shrink the cancer or make surgery more effective.

What is CAPEOX?

CAPEOX is a combination of two chemotherapy drugs, capecitabine and oxaliplatin, used to treat colon cancer.

What is dostarlimab?

Dostarlimab is a type of immunotherapy drug that helps your body's immune system fight cancer.

Why is it important if my cancer has 'normal DNA repair systems'?

This refers to special characteristics of the cancer cells. Researchers believe that if your cancer has these normal repair systems, it might respond differently to the new drug, dostarlimab.

Can I still get my usual cancer care if I decide not to join the study?

Yes, absolutely. Deciding not to participate, or withdrawing from the study, will not affect your standard medical care in any way.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

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