A Phase 3 study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 positive Colorectal Cancer (KEYFORM-007)
This study, called KEYFORM-007, is testing a new combination medicine called MK-4280A for people with bowel cancer that has spread to other parts of the body (metastatic) and has already been treated with other medicines. The study wants to see if MK-4280A is better than the usual treatments doctors give. Researchers will carefully watch how long people live, if their cancer grows, and how they feel overall. They will also look at any side effects people might have and how the treatment affects their daily life. The main goal is to find out if this new treatment can offer a better option for advanced bowel cancer patients.
At a glance
What is this study about?
This study is about a type of cancer that starts in the large bowel, called colorectal cancer. When this cancer spreads to other parts of the body, it's called metastatic. This study is for people whose cancer has already been treated with other medicines.
The researchers are testing a new medicine called MK-4280A. This medicine is actually a combination of two drugs, favezelimab and pembrolizumab, which work together to help your body's immune system fight the cancer. They want to see if this new combination works better than the standard treatments already available, such as trifluridine or regorafenib.
The main thing the doctors want to find out is whether MK-4280A helps people with this type of cancer live longer. They will also look at how the cancer responds to the treatment, if it slows down its growth, and if it improves how people feel and their quality of life. This is a "Phase 3" study, which means it's one of the final steps before a new medicine might be approved for wider use, if it's shown to be safe and effective.
Key takeaways
- This study is for advanced bowel cancer that has already been treated.
- It tests a new drug combination, MK-4280A, against current standard treatments.
- The main aim is to see if the new treatment helps people live longer.
- It also checks for side effects and improvements in quality of life.
- Your cancer needs to be 'PD-L1 positive' to be considered for this study.
- Participation involves regular clinic visits and health checks.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. Both men and women can take part. The study is specifically for people who have colorectal cancer that has spread to other parts of the body, and who have already received previous treatments for their cancer.
Another important point is that your cancer must have a specific characteristic called "PD-L1 positive." This means that your cancer cells have a certain marker on their surface, which helps identify if the new medicine might be effective for you. Your doctor will be able to check for this.
Not everyone with colorectal cancer will be able to join. The study has other detailed requirements, which your doctor will explain after reviewing your full medical history and test results. They will make sure joining this study is the right choice for you.
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?
- Do you have colorectal cancer that has spread?
- Has your cancer already been treated with other medicines?
- Has your doctor confirmed that your cancer is 'PD-L1 positive'?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you join this study, you will either receive the new combination medicine, MK-4280A, or one of the standard treatments for your cancer (trifluridine or regorafenib). You won't get to choose which treatment you receive; it will be decided randomly, like flipping a coin. You will have regular visits to the clinic for assessments, which will include physical exams, blood tests, and scans to see how your body is responding to the treatment and how the cancer is doing. You will also be asked to complete questionnaires about how you are feeling and your quality of life. The treatment will continue as long as it is helping you and you are not experiencing severe side effects. The total duration of your participation in the study will depend on how you respond to the treatment and the follow-up schedule.
Potential risks and benefits
Locations (4)
- —UnverifiedItaly
- —UnverifiedNorway
- —UnverifiedFrance
- —UnverifiedSpain
Common questions
What is colorectal cancer?
Colorectal cancer is cancer that starts in the large bowel, which includes the colon or rectum.
What does 'metastatic' mean?
Metastatic means the cancer has spread from where it started to other parts of the body.
What is 'standard of care'?
Standard of care refers to the usual, accepted treatments that doctors use for a particular condition.
Will I know if I'm getting the new drug or standard treatment?
No, in this type of study, it's usually decided randomly, and you won't know which treatment you are receiving until the study is over.
What does 'PD-L1 positive' mean for my cancer?
It means your cancer cells have a specific marker that helps doctors decide if certain modern treatments, like the one in this study, might work well for you.
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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