GSK AZUR-2 Colon Cancer Study

A clinical research study for adults with untreated colon cancer that has not spread

Photograph of various adults of different ethnicities working on a puzzle, the AZUR Study for adults with colon cancer

GSK AZUR-2 219606 Study

A clinical research study for adults with untreated colon cancer that has not spread

Join the Study

What is a clinical study?

Clinical studies are research studies that help doctors and scientists learn more about a disease or medical condition and find new ways to treat, diagnose, or prevent it. They are also called clinical trials.

Photograph of an older caucasian woman in a dance class, the AZUR Study for adults with colon cancer

Who can participate?

You may qualify for this study if you are 18 years of age or older and have colon cancer that:

Tumor biomarkers

Has specific DNA defects (dMMR/MSI-H).*

Treatment

Is not yet treated.

Has not spread to distant parts of the body.

*dMMR = deficient mismatch repair; MSI-H = high microsatellite instability.

Additional participation criteria also apply.

What is the GSK AZUR-2 219606 Study?

This study is being done to learn more about the study drug, dostarlimab, used before and after surgery to see whether it can safely treat adults with colon cancer that has not spread. Dostarlimab is a type of drug that helps your immune system fight cancer (immunotherapy). The effects of dostarlimab + surgery will be compared with those of standard treatment (surgery with or without chemotherapy).

Frequently Asked Questions

Understanding the GSK AZUR-2 219606 Study

Illustration of a female doctor talking to an older African American couple, the AZUR Study for adults with colon cancer

What happensduring the study?

You will first need to give your consent, or permission, to join the study by reading and signing the Informed Consent Form.

There are 4 parts to this study. The amount of time you spend in the study will depend on which study treatment you receive.

Pre-screening (if needed)

The study team will make sure your cancer is dMMR and MSI-H before you join the study. They will test a sample of your tumor for these markers if it hasn’t been tested already.

Screening

To see if you qualify for the study, the study doctor/study nurse will ask questions about your health and the medicines you take and will run some tests.

Study Treatment

You will be assigned by chance to receive:

The study drug (dostarlimab) for 12 weeks before surgery and 36 weeks after surgery

Standard treatment (surgery with or without chemotherapy). If prescribed, chemotherapy will be given for 12 to 24 weeks after surgery. Standard treatment options will be decided together with your study doctor

You’re twice as likely to be assigned to the study drug group than to the standard treatment group.

The study drug is given by intravenous (IV) infusion every 3 weeks before surgery and every 6 weeks after surgery. An IV infusion means the medicine is given slowly through a needle into a vein in your arm.

You will have visits with tests to check on your health and to see how your cancer is responding to treatment. The number of visits you will have will depend on your assigned group.

Follow-up

You will have visits 30 days and 90 days after finishing the Study Treatment Period or surgery, if you are not receiving study treatment. You’ll then have a visit approximately every 6 months for the next few years. Some of these visits may take place over the phone.

What kinds of tests and health checks can I expect?

Some of the tests you may have during the study are shown below. You will not have all of these tests at every visit. Talk to the study doctor to learn more.