RecruitingPHASE2INTERVENTIONAL

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer

This research study is investigating new treatment options for people with advanced colorectal cancer that has spread to other parts of the body, but not to the liver. The main goal is to find out if combining a new drug called Volrustomig with a standard chemotherapy regimen (FOLFIRI) and an additional cancer drug (Bevacizumab) is safe and works better than the standard treatment alone. Participants will be randomly assigned to receive either the combined new treatment or just the standard treatment. The study is particularly looking for people whose cancer has a specific genetic makeup (pMMR/MSS) and who haven't had previous strong treatments for their advanced cancer. This is a Phase II study, meaning it's still in the earlier stages of drug development, focusing on safety and how well the treatment works.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

AstraZeneca

Enrolment target

120

Start

12 Mar 2025

Estimated completion

07 Jun 2028

Metastatic Colorectal Cancer

What is this study about?

This study is looking for better ways to treat a type of advanced bowel cancer (colorectal cancer) that has spread to other parts of the body. When cancer spreads, it's called metastatic. The researchers are particularly interested in patients whose cancer has spread but hasn't reached the liver, and who haven't had previous strong treatments for their advanced cancer. They are also focusing on a specific genetic characteristic of the cancer, known as Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS).

The study involves testing a new drug called Volrustomig. This drug will be given alongside a widely used chemotherapy combination known as FOLFIRI (which includes Fluorouracil, leucovorin, and irinotecan) and another cancer drug, Bevacizumab. One group of participants will receive this combination with Volrustomig, while another group will receive only the FOLFIRI and Bevacizumab combination, which is a standard approach. The aim is to see if adding Volrustomig makes the treatment safer and more effective for these patients.

This is a Phase II study, which means it's an earlier stage of research designed to gather more information about the treatment's safety and how well it works, before it can be considered for wider use. It's an important step in potentially improving treatment options for people living with advanced colorectal cancer.

Key takeaways

Tests a new drug (Volrustomig) for advanced bowel cancer.
Compares it with a standard treatment combination.
Focuses on specific cancer types not spread to the liver.
Aims to assess safety and effectiveness of the new combination.
Participation involves regular clinic visits and tests.

Who may be eligible?

To be considered for this study, you would need to have bowel cancer that has been confirmed by a biopsy and has spread to other parts of your body. Doctors would also need to see that your cancer can be measured and that you are generally well enough to take part, with a life expectancy of at least 12 weeks.

Specifically for this part of the study, your cancer must not have spread to your liver. You should also not have received strong treatments for your advanced cancer before, though some earlier chemotherapy treatments are allowed if they were a long time ago. Your cancer also needs to have a specific genetic make-up (pMMR/MSS). Your organs, like your kidneys and bone marrow, need to be working properly, and your weight needs to be over 35 kg.

However, you would not be able to join if your cancer has spread to your brain or spinal cord, or if you have a history of severe allergies to certain medications. You also can't have any significant side effects from previous cancer treatments that haven't cleared up. Other reasons for not being able to join include having another type of cancer in your past, specific heart or autoimmune conditions, or a history of specific blood clots or bleeding risks. If your cancer could potentially be removed by surgery, or if you've had certain stomach or bowel problems recently, you would also not be eligible.

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.

Have you been diagnosed with advanced bowel cancer that has spread?
Has your cancer NOT spread to your liver?
Have you not had strong treatments for your advanced cancer before?
Are your organs generally healthy (e.g., kidneys, bone marrow)?
Do you have a specific genetic type of cancer (pMMR/MSS status)?
Do you have no severe allergies to medications or specific heart/autoimmune conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will receive the new drug Volrustomig along with the standard FOLFIRI chemotherapy and Bevacizumab. The other group will receive the standard FOLFIRI chemotherapy and Bevacizumab without Volrustomig. Both treatments involve infusions, typically given in a hospital setting. You will have regular visits to the clinic for medical examinations, blood tests, and scans to monitor your health and how the treatment is working. Doctors will carefully track any side effects you might experience. The total duration for each person's participation will vary depending on how they respond to the treatment and the study plan, but you will be closely followed throughout.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new and promising treatments that are not yet widely available. While the new drug Volrustomig is being tested, it might prove to be a more effective treatment for your cancer. However, like all medications, potential risks exist, and you may experience side effects from the study treatments. These will be carefully explained to you by the study team, and you will be monitored closely. There is also no guarantee that the treatment will be effective for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (76)

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

Research Site
Verified postcode
Scottsdale, United States· Recruiting
Research Site
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Los Angeles, United States· Recruiting
Research Site
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Washington D.C., United States· Not yet recruiting
Research Site
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Chicago, United States· Not yet recruiting
Research Site
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Baltimore, United States· Recruiting
Research Site
Verified postcode
Boston, United States· Completed
Research Site
Verified postcode
Rochester, United States· Recruiting
Research Site
Verified postcode
Trenton, United States· Not yet recruiting
Research Site
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Rochester, United States· Recruiting
Research Site
Verified postcode
Cleveland, United States· Withdrawn
Research Site
Verified postcode
Portland, United States· Not yet recruiting
Research Site
Verified postcode
Philadelphia, United States· Withdrawn

Common questions

What is FOLFIRI and Bevacizumab?

FOLFIRI is a standard combination of chemotherapy drugs often used for bowel cancer. Bevacizumab is another drug that targets cancer by blocking the growth of new blood vessels that feed the tumour.

What is Volrustomig?

Volrustomig is an investigational drug, meaning it's still being studied. Researchers are hoping it can improve the effectiveness of existing treatments for advanced bowel cancer.

What does 'pMMR/MSS' mean for my cancer?

This refers to a specific genetic feature of your cancer, which helps doctors understand how it might respond to certain treatments. In this study, only cancers with this particular feature are included.

Will I know if I'm getting the new drug or the standard treatment?

No, this is a 'blinded' study, meaning neither you nor your doctors will know which treatment arm you are in. This helps ensure the study results are as fair and unbiased as possible.

Does this study involve surgery?

This study is focused on drug treatments and does not involve surgery as a primary part of the intervention. In fact, if your cancer could be completely removed by surgery, you would not be eligible for this specific study.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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