A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)
This important research is a Phase 3 study, which means it's a key step in testing new treatments. It's for people with bowel cancer that has spread to other parts of the body. Participants will receive one of two treatment combinations: either a new drug called ivonescimab with a standard chemotherapy mix (FOLFOX), or an existing drug called bevacizumab with the same FOLFOX chemotherapy. Doctors want to find out which combination is better at slowing down or stopping the cancer's growth. They will also look at how long people live, if the tumours shrink, and what side effects might happen. The aim is to find safer and more effective ways to treat metastatic colorectal cancer.
At a glance
What is this study about?
This research study is an important step in finding the best treatments for bowel cancer that has spread to other parts of the body, also known as metastatic colorectal cancer. Bowel cancer is a common type of cancer, and when it spreads, it can be more challenging to treat. Doctors are always looking for new and improved ways to help patients.
In this study, two different treatment combinations are being compared. Everyone in the study will receive a standard chemotherapy treatment called FOLFOX. This is a mix of three medicines: Folic acid, Oxaliplatin, and Fluorouracil. On top of this, some people will get a new medicine called ivonescimab, while others will receive an existing medicine called bevacizumab. Both ivonescimab and bevacizumab are types of targeted therapies, which means they are designed to attack cancer cells in specific ways.
The main goal of the study is to see which of these combinations is better at stopping the cancer from growing or spreading further. This is measured by how long people live without their cancer getting worse, known as 'progression-free survival'. The researchers will also look at how long people live overall, whether tumours shrink, and what side effects might occur with each treatment. We hope this study will provide valuable information to help doctors make the best treatment choices for patients with metastatic colorectal cancer in the future.
Key takeaways
- This study is testing new treatments for bowel cancer that has spread.
- It compares two different drug combinations, both including standard chemotherapy.
- The main goal is to find which treatment best stops cancer from growing.
- Participation involves regular hospital visits for treatment and monitoring.
- Your doctor can help you understand if this study might be right for you.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. The study is open to both men and women.
Critically, you must have been diagnosed with bowel cancer (colorectal cancer) that has spread to other parts of your body. This study is specifically for your first treatment of this spread cancer.
There will be other detailed medical checks to make sure the study is a safe and suitable option for you. These might include reviewing other health conditions you have, or previous treatments you've received. Your doctor will discuss all of these with you carefully.
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?
- Have you been diagnosed with bowel cancer that has spread?
- Is this your first treatment for your spread bowel cancer?
- Are you generally well enough to start a new treatment?
What does participation involve?
If you decide to take part, you'll be assigned to one of the two treatment groups — either ivonescimab with FOLFOX, or bevacizumab with FOLFOX. This is done randomly, like flipping a coin, so neither you nor your doctor can choose which treatment you get. You, and often your doctors, won't know which specific drug (ivonescimab or bevacizumab) you are receiving; this is called 'double-blind'.
You'll have regular hospital visits for your treatment, which is given into a vein (intravenously). During these visits, you'll have blood tests, physical exams, and scans (like CT or MRI) to check how well the treatment is working and monitor for any side effects. You'll also be asked about your general health and how you're feeling. The treatment will continue as long as it's helping and you're not experiencing severe side effects. After your treatment finishes, there will be follow-up visits or calls to keep an eye on your health. The total duration of participation, including follow-up, will depend on how your cancer responds to treatment and how long you are able to continue with it.
Potential risks and benefits
Locations (8)
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedPoland
- —UnverifiedCzechia
- —UnverifiedHungary
Common questions
What does 'metastatic' mean?
'Metastatic' means the cancer has spread from where it started in the bowel to other parts of the body.
What is FOLFOX?
FOLFOX is a common combination of three chemotherapy drugs used to treat bowel cancer.
What is a 'Phase 3' study?
A Phase 3 study is the final stage of testing a new treatment before it can be considered for wider use, comparing it to existing treatments.
Will I know which treatment I'm getting?
Because it's a 'double-blind' study, neither you nor your study doctor will know whether you are receiving ivonescimab or bevacizumab.
What does 'PFS' mean?
PFS stands for 'Progression-Free Survival,' which is how long a person lives with the disease without it getting worse.
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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