A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
This study is for people in the UK with advanced bowel cancer that has spread to other parts of the body and can't be removed by surgery. It's for people who have already had some treatment for their cancer. The study is comparing a new drug called magrolimab, given alongside standard treatments (bevacizumab and FOLFIRI), with just the standard treatments alone. Researchers want to find out if adding magrolimab is safe and if it helps to stop the cancer from growing or spreading for longer. This is a Phase 2 study, which means it's an early-stage trial looking at how well the new treatment works and if it has any side effects.
At a glance
What is this study about?
This research study is about finding better ways to treat advanced bowel cancer, also known as metastatic colorectal cancer. When cancer is 'advanced' and 'metastatic', it means it has spread from where it started to other parts of your body. 'Inoperable' means that doctors can't remove the cancer with surgery. This study is for people who have already received some treatment for their cancer but are now looking for other options.
The study is looking at a new drug called magrolimab. Researchers want to see how this new drug works when it's given together with a combination of standard treatments that are already used for this type of cancer. These standard treatments include bevacizumab (also known as Avastin) and a chemotherapy regimen called FOLFIRI (which includes drugs like irinotecan, leucovorin, and fluorouracil).
The main goal is to find out if adding magrolimab to the standard treatment is safe and if it can help stop the cancer from growing or spreading for a longer time. They will also be carefully checking for any side effects. This is a 'Phase 2' study, which means it’s an important step in testing new treatments to understand their benefits and any potential risks before they can become widely available.
Key takeaways
- This study evaluates a new drug, magrolimab, for advanced bowel cancer.
- It combines magrolimab with standard treatments (bevacizumab and FOLFIRI).
- It's for people with inoperable, metastatic colorectal cancer who have had previous treatment.
- The main goals are to check safety and how long patients live without their cancer worsening.
- Taking part means regular hospital visits for treatment and monitoring over a few years.
Who may be eligible?
This study is looking for adults aged 18 and over who have advanced bowel cancer that has spread and cannot be treated with surgery. You would also need to have already received some treatment for your cancer in the past.
Both men and women can take part in this study. The medical team will carefully check other details, such as your general health and specific cancer features, to make sure the study is a good fit for you and that taking part would be safe.
It's important to discuss your medical history with the study team. They will ensure that participation in this particular trial is appropriate for your individual situation.
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.
- I am 18 years old or older.
- I have advanced bowel cancer that has spread (metastatic).
- My cancer cannot be removed by surgery.
- I have already received some treatment for my cancer.
- I am willing to have regular hospital visits for treatment and check-ups.
What does participation involve?
If you decide to take part, you would be assigned to one of two groups by chance (like flipping a coin). One group will receive the new drug magrolimab along with the standard treatments (bevacizumab and FOLFIRI), and the other group will receive just the standard treatments. You won't know which group you are in, and neither will your doctors, for some aspects of the study.
You would receive your treatments, which are given as infusions (drips), at the hospital. You'll have regular hospital visits for these treatments and for check-ups. These check-ups will involve blood tests, scans (like CT scans) to monitor your cancer, and discussions about how you're feeling and any side effects you might be experiencing. The study will monitor your health and cancer progression for up to three years, though your treatment schedule might change based on how your cancer responds.
Potential risks and benefits
Locations (5)
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedBelgium
- —UnverifiedItaly
Common questions
What is 'advanced metastatic colorectal cancer'?
This means bowel cancer that has spread from its original site to other parts of your body and cannot be removed by surgery.
What are 'standard treatments'?
These are treatments that are already approved and commonly used by doctors for your type of cancer, such as bevacizumab and FOLFIRI chemotherapy.
What is a 'Phase 2' study?
This is an early stage of clinical research where doctors test a new treatment to see how well it works and if it has any side effects before it can be widely used.
Will I know which treatment I'm getting?
No, you will be assigned to a group by chance. This helps make sure the study results are fair and unbiased.
How long does the study last?
The study will monitor your health and cancer for up to three years, but your active treatment might be for a shorter period depending on your individual response.
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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