A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
This research study is investigating a new drug called INCA33890 for people with advanced bowel cancer that has spread to other parts of the body. This type of cancer is known as 'metastatic microsatellite stable colorectal cancer.' The study is comparing the usual chemotherapy and another drug called bevacizumab, with or without the new drug INCA33890. Researchers want to find out if adding INCA33890 helps slow down the cancer's growth and improves how long people live. Participants will be split into groups, with some receiving the new drug and others a dummy treatment (placebo), alongside their standard care, so we can clearly see the effects of INCA33890. This is a crucial step to see if this new treatment could become a standard option in the future.
At a glance
What is this study about?
This study is about people who have a type of advanced bowel cancer that has spread to other parts of their body. Doctors call this 'metastatic microsatellite stable colorectal cancer.' Unfortunately, at this stage, the cancer is harder to treat. Doctors are always looking for better ways to help people in this situation.
The main idea behind this study is to test a new drug, called INCA33890. It's being added to the standard treatments that people with this type of cancer usually receive. These standard treatments include special chemotherapy drugs (like oxaliplatin and fluorouracil) and another drug called bevacizumab, which helps to stop the cancer from forming new blood vessels. The study wants to see if adding INCA33890 to these existing treatments makes them even more effective.
To make sure the study provides clear answers, participants will be randomly put into two groups. One group will get the standard treatments plus INCA33890, and the other group will get the standard treatments plus a 'placebo.' A placebo looks just like the study drug but doesn't contain any active medicine. This helps researchers compare the two groups fairly and find out if INCA33890 truly helps. The main things the doctors will be looking for are how long people live without their cancer growing, and how long they live overall.
Key takeaways
- This study tests a new drug (INCA33890) for advanced bowel cancer.
- It combines INCA33890 with standard treatments (chemotherapy and bevacizumab).
- The aim is to see if it helps keep cancer from growing and improves how long people live.
- Participants will be randomly assigned to receive either the new drug or a placebo.
- Close monitoring for health and treatment effects is a key part of the study.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you would need to be an adult, at least 18 years old. The study is open to both men and women.
The most important thing is that you have a specific type of advanced bowel cancer. This is called 'metastatic microsatellite stable colorectal cancer.' This means your bowel cancer has spread to other parts of your body, and tests have shown it belongs to the 'microsatellite stable' group.
There might be other health requirements too, which your doctor would discuss with you to make sure the study is a safe and suitable option 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?
- Have you been diagnosed with bowel cancer that has spread?
- Has your cancer been identified by tests as 'microsatellite stable'?
- Are you able to receive standard chemotherapy and bevacizumab treatments?
What does participation involve?
If you decide to take part in this study, you would receive the study treatment (either INCA33890 or the placebo) along with your regular chemotherapy and bevacizumab. You wouldn't know which group you are in, and neither would your doctors, to keep the results fair. You would have regular visits to the hospital for your treatments and check-ups. These visits would include blood tests, scans, and physical exams to monitor your health and how the treatment is working. Doctors would also carefully record any side effects you experience. The total time you would be on the study treatment would depend on how your cancer responds and how you tolerate the treatment, but you will be monitored for your health and the cancer’s progress for a longer period.
Potential risks and benefits
Locations (10)
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Common questions
What does 'metastatic' mean?
It means the cancer has spread from where it started in the bowel to other parts of your body.
What is a 'placebo'?
A placebo is adummy medication that looks like the real study drug but doesn't contain any active medicine. It's used for fair comparison.
Will I know if I'm getting the new drug or the placebo?
No, neither you nor your doctors will know, so the study's results are as unbiased as possible.
What is 'standard-of-care' chemotherapy?
This refers to the usual treatments that are accepted and widely used by doctors for this type of cancer.
What if the new drug causes serious side effects?
Your health will be closely monitored by doctors and nurses, and they will help manage any side effects you might experience.
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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