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Active not recruitingPHASE3INTERVENTIONAL

Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

This research study is looking at advanced bowel (colorectal) cancer that has spread to other parts of the body. Specifically, it's for people whose cancer is known as 'microsatellite stable' or 'MSI-low' and hasn't responded well to previous standard treatments, or they couldn't tolerate them. Researchers want to compare two different treatment plans: one involves a drug called XL092 given alongside another drug called atezolizumab, and the other plan uses a drug called regorafenib. The main goal is to find out which of these treatments is more effective at managing the cancer and improving patients' health. This type of study, known as Phase 3, helps doctors understand if new treatments are better than existing ones.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Exelixis
Enrolment target
901
Start
07 Sep 2022
Estimated completion
01 Jan 2027

What is this study about?

This study is for people in the UK who have colorectal cancer (often called bowel cancer) that has spread to other parts of the body, which doctors call 'metastatic'. If your cancer has been checked and is described as 'microsatellite stable' or 'MSI-low', and standard treatments haven't worked well for you, or you couldn't tolerate them, this study might be relevant.

The main aim of this research is to see if a combination of two drugs – XL092 and atezolizumab – works better than another drug called regorafenib. All these medicines are designed to fight cancer, but they work in different ways. By comparing them, doctors hope to find a more effective treatment option for this type of advanced bowel cancer.

This is a 'Phase 3' study, which means it's a very important stage of research. It's designed to confirm whether new treatments are safe and effective, and if they offer benefits over existing ones. Your participation would help doctors learn more and potentially improve future treatments for people with bowel cancer.

Key takeaways

  • Two cancer treatment approaches are being compared.
  • For advanced bowel cancer that hasn't responded to other treatments.
  • Your cancer needs to be 'microsatellite stable' or 'MSI-low'.
  • Participation involves regular clinic visits and monitoring.
  • This is a Phase 3 study, aiming to find better treatments.
  • You can withdraw at any time without affecting your care.

Who may be eligible?

To join this study, people need to have bowel cancer that has been confirmed by a lab test and has spread. Doctors will need to know specific information about your cancer, like its 'RAS' status and confirmation that it's 'microsatellite stable' or 'MSI-low' – tests that your doctor will have done. You must have already tried standard cancer treatments for your advanced bowel cancer, and your cancer must have either grown or you couldn't continue those treatments.

You also need to have cancer that can be measured on scans, which helps doctors track how well the treatment is working. Your general health and fitness, measured by something called an 'ECOG performance status' (which means you're generally active and can look after yourself), should be good. You'll also need to have healthy organ function, like your liver and kidneys. For women who could become pregnant and their partners, it's important to agree to use effective birth control during and after the study.

However, you won't be able to join if you've already had certain specific treatments, including XL092, regorafenib, or particular types of immune medicines. Also, if you've recently had other small molecule kinase inhibitor drugs (including those used in other research studies) in the last two weeks, you wouldn't be able 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.

  1. Do I have bowel cancer that has spread?
  2. Has my cancer been tested as 'microsatellite stable' or 'MSI-low'?
  3. Have standard treatments for my advanced bowel cancer stopped working or not been tolerated?
  4. Am I generally active and able to look after myself?
  5. Do I have cancer that can be measured on a scan?
  6. Have I avoided certain specific cancer drugs recently?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the combination of XL092 and atezolizumab, or the drug regorafenib. You wouldn't get to choose which one; this is decided randomly, like flipping a coin. You would have regular visits to the clinic for medical check-ups, blood tests, and scans to see how your cancer is responding to the treatment. Doctors would also carefully monitor you for any side effects from the medication. The exact number of visits and the total length of the study would be discussed with you by the study team, but it will involve ongoing treatment and follow-up for as long as the treatment is benefiting you, and potentially beyond.

Potential risks and benefits

Taking part in this study could offer the chance to receive a new combination treatment that might be more effective for your cancer than existing options. However, as with any medicine, there are potential risks of side effects. These could range from mild to more serious, and the study team will carefully explain what to look out for and how they will manage them. You will also have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (133)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Exelixis Clinical Site #65
    Verified postcode
    Jonesboro, United States
  • Exelixis Clinical Site #30
    Verified postcode
    Phoenix, United States
  • Exelixis Clinical Site #70
    Verified postcode
    Tucson, United States
  • Exelixis Clinical Site #9
    Verified postcode
    Duarte, United States
  • Exelixis Clinical Site #55
    Verified postcode
    La Jolla, United States
  • Exelixis Clinical Site #77
    Verified postcode
    Los Angeles, United States
  • Exelixis Clinical Site #105
    Verified postcode
    Orange, United States
  • Exelixis Clinical Site #80
    Verified postcode
    Santa Monica, United States
  • Exelixis Clinical Site #5
    Verified postcode
    Santa Rosa, United States
  • Exelixis Clinical Site #82
    Verified postcode
    Sylmar, United States
  • Exelixis Clinical Site #58
    Verified postcode
    Torrance, United States
  • Exelixis Clinical Site #81
    Verified postcode
    Whittier, United States

Common questions

What is 'metastatic colorectal cancer'?

It means bowel cancer that has spread from where it started to other parts of your body.

What does 'microsatellite stable' or 'MSI-low' mean?

These are medical terms that describe certain features of your cancer cells, which doctors find out from lab tests. It helps them decide which treatments might work best.

What are XL092, atezolizumab, and regorafenib?

These are different medicines used to treat cancer. They work in various ways to try and stop cancer cells from growing.

Why am I being asked to provide a tissue sample?

The researchers need to study your cancer tissue to understand more about it and to confirm that you meet the study requirements.

Can I choose which treatment I receive?

No, in this type of study, a computer will randomly decide whether you receive the XL092 plus atezolizumab combination or regorafenib. This helps ensure fair comparison.

How to find out more

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

Discussion

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