AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer Expressing c-Met Protein Level Above a Defined Cutoff
This important study, called AndroMETa-CRC-064, is looking into new ways to treat advanced bowel cancer (metastatic colorectal cancer) that has spread in the body. It's for patients whose cancer has a particular protein called c-Met. Researchers want to see if a new medicine, Telisotuzumab Adizutecan, works better and is safer than the current standard treatment, which is a combination of Lonsurf and Bevacizumab. During the trial, doctors will carefully monitor patients for any side effects and see how well each treatment helps to shrink or control the cancer. The study is particularly interested in how long people live and how their cancer responds to treatment, aiming to improve future care for bowel cancer patients.
At a glance
What is this study about?
This study, known as AndroMETa-CRC-064, is a type of research called a "Phase 3 trial." This means it's a large, careful study that compares a new treatment with an existing one. We already have treatments for bowel cancer that has spread (metastatic colorectal cancer), but doctors are always looking for even better options. This trial is specifically for people whose cancer cells have higher levels of a certain protein called 'c-Met'. This protein can sometimes help cancer grow and spread, so targeting it might be a way to fight the disease more effectively.
The trial is comparing two approaches. One group of patients will receive a new medicine called Telisotuzumab Adizutecan. This drug is designed to attack cancer cells that have the c-Met protein. The other group will receive a combination of two standard medicines: Lonsurf (which is a tablet containing Trifluridine and Tipiracil) and Bevacizumab (an injection). Both these treatments are already used for advanced bowel cancer. By comparing them side-by-side, researchers hope to discover if the new medicine offers a better way forward.
The main goals of this study are to understand how safe each treatment is (by tracking side effects) and how effective it is. Effectiveness means seeing how well the treatments shrink the cancer or stop it from growing, and ultimately, how they impact patients' lives and overall health. The results will help doctors decide if Telisotuzumab Adizutecan should become a new option for people with this type of bowel cancer.
Key takeaways
- This study is for advanced bowel cancer that has spread.
- It's comparing a new drug with a standard treatment.
- The new drug targets a specific protein called c-Met.
- Participation involves regular visits and medical checks.
- You will know which treatment you receive.
- You can leave the study at any time.
Who may be eligible?
To be able to join this study, participants generally need to be at least 18 years old. Both men and women can take part. A very important part of deciding who can join is checking if your bowel cancer has spread to other parts of your body, and if it has a specific protein called 'c-Met' at a certain level. This will be checked by your doctors.
The study is for people who have already had some treatments for their advanced bowel cancer, and those treatments haven't worked as well as hoped, or the cancer has come back. There will be other specific health checks and tests to make sure that taking part in the study is as safe as possible for you. Your medical team will go through all these details with 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?
- Has your bowel cancer spread to other parts of your body?
- Have your doctors confirmed that your cancer has the specific 'c-Met' protein?
- Have you already had some treatment for your advanced bowel cancer, and it hasn't worked as hoped?
- Are you able to travel to a hospital or clinic for regular appointments?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to receive either the new medicine (Telisotuzumab Adizutecan) or the standard treatment (Lonsurf tablets plus Bevacizumab injections). This means there's a 50/50 chance of getting either. You won't be able to choose which treatment you receive.
You would have regular hospital visits for check-ups, blood tests, heart checks (ECGs), and to receive your medication. These visits will help doctors monitor your health, look for any side effects, and see how the treatment is working. You'll also have scans to track your cancer. The length of time you'd be on the study treatment would depend on how you respond and whether you experience any side effects. You would continue treatment as long as it is benefiting you and is safe.
Potential risks and benefits
Locations (6)
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- —UnverifiedFrance
- —UnverifiedItaly
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- —UnverifiedSpain
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 is the 'c-Met protein'?
It's a specific protein that can be found on cancer cells, and it might help the cancer grow. This study focuses on cancers with high levels of it.
What is a 'Phase 3 study'?
It's a large, important stage of testing a new treatment, comparing it against existing standard treatments to see if it's better.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, meaning you and your doctors will know which treatment you are receiving.
Can I stop participating in the study if I want to?
Yes, you can choose to leave the study at any point, and your decision won't affect your future medical care.
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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