A Study to Evaluate the Efficacy and Safety 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 looking into a new treatment for advanced bowel cancer that has spread to other parts of the body. The study plans to test a new drug called INCA33890. This new drug will be given alongside chemotherapy (FOLFOX) and another well-known medicine called bevacizumab, which are already used to treat this type of cancer. The main goal is to find out if adding INCA33890 improves how well the treatment works and if it is safe for patients. Some patients will receive the new drug, while others will receive a placebo (a dummy drug) to compare the results fairly. This is for patients whose cancer has specific features (called 'microsatellite stable').
At a glance
What is this study about?
When bowel cancer spreads to other parts of the body, it's called metastatic colorectal cancer. Treatments for this type of cancer aim to help people live longer and improve their quality of life. This study is testing if adding a new drug, called INCA33890, to the usual care makes treatment even better.
The usual care in this study involves a type of chemotherapy called FOLFOX and another medicine called bevacizumab. These treatments are already known to work for this kind of cancer. Researchers want to see if INCA33890, when given alongside these established treatments, can improve the results for patients. This includes looking at how effectively the cancer is controlled and how safe the new drug combination is.
Patients in this study will be split into groups. Some will receive INCA33890 along with their usual chemotherapy and bevacizumab, while others will receive a 'placebo' (a dummy drug without active ingredients) instead of INCA33890, still alongside their usual treatment. This is a common way to test new medicines fairly, so doctors can compare whether the new drug makes a real difference. The study is specifically for patients whose bowel cancer has a certain genetic characteristic, known as 'microsatellite stable'.
Key takeaways
- This study evaluates a new drug (INCA33890) for advanced bowel cancer.
- It combines the new drug with standard chemotherapy (FOLFOX) and bevacizumab.
- The aim is to see if INCA33890 improves treatment effectiveness and safety.
- Participants will receive either the new drug or a placebo alongside standard care.
- The study is for bowel cancer that has spread and has specific characteristics.
- Regular hospital visits, treatments, and monitoring will be required.
Who may be eligible?
To join this study, you would need to have bowel cancer that has spread and cannot be removed by surgery. This would be your first treatment for the cancer once it has spread. If you've had chemotherapy for bowel cancer before, it would need to have been more than 12 months ago and the cancer did not return.
Your general health would need to be good, meaning you can carry out most of your daily activities without much trouble. Doctors would also check that your organs, like your kidneys and liver, are working well through blood tests. Your cancer would also need to be visible on scans, so doctors can measure how it responds to treatment.
There are also some reasons why you might not be able to join. For example, if your medical records show specific genetic changes in your cancer (called MSI-H/dMMR or BRAF V600E mutation), you wouldn't be eligible. Also, if you have certain other serious health conditions, or if you've recently had treatments that affect your immune system, you might not be able to take part. The study doctors will go through all the detailed requirements 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.
- My bowel cancer has spread and cannot be removed by surgery.
- This would be my first treatment for the cancer after it has spread.
- I haven't had recent treatment that affects my immune system.
- Doctors have confirmed my cancer isn't MSI-H/dMMR or BRAF V600E mutated.
- I am generally well and can carry out most daily activities.
- My organ functions (like liver and kidneys) are healthy.
What does participation involve?
Taking part in this study would involve regular visits to the hospital for treatment and check-ups. You would receive chemotherapy (FOLFOX) and bevacizumab, along with either the new investigational drug (INCA33890) or a placebo. This would be given through drips, likely every two weeks for a period, though the exact schedule will be explained in detail.
Throughout the study, you would have regular assessments, including blood tests, physical examinations, and scans (like CT scans) to monitor your cancer and check for any side effects. You'd also be asked about how you're feeling. The total duration of your active treatment would depend on how your cancer responds and how you tolerate the treatment. Even after stopping treatment, you would likely have follow-up visits or calls for a period to see how you are doing in the long term. You would receive all necessary study medication as part of your participation.
Potential risks and benefits
Locations (274)
- Ironwood Cancer & Research CentersVerified postcodeChandler, United States· Withdrawn
- The University of Arizona Cancer CenterVerified postcodeTucson, United States· Not yet recruiting
- Roche Tissue Diagnostics, Companion DiagnosticsVerified postcodeTucson, United States· Recruiting
- Los Angeles Cancer NetworkVerified postcodeAnaheim, United States· Not yet recruiting
- Memorial Care Orange Coast Medical CenterVerified postcodeFountain Valley, United States· Recruiting
- Providence Medical FoundationVerified postcodeFullerton, United States· Not yet recruiting
- Cancer & Blood Research CenterVerified postcodeLos Alamitos, United States· Not yet recruiting
- University of California Los Angeles HealthVerified postcodeLos Angeles, United States· Not yet recruiting
- Sarah Cannon Research Institute Scri Oncology PartnersVerified postcodeAurora, United States· Recruiting
- Hartford HospitalVerified postcodeHartford, United States· Not yet recruiting
- George Washington UniversityVerified postcodeWashington D.C., United States· Not yet recruiting
- Florida Oncology & HematologyVerified postcodeFort Myers, United States· Recruiting
Common questions
What is 'metastatic' bowel cancer?
This means your bowel cancer has spread from where it started to other parts of your body.
What is a 'placebo'?
A placebo is adummy drug that looks like the active study drug but doesn't contain any active ingredients. It's used to fairly compare the effects of the new drug.
What is 'first-line treatment'?
This means the study treatment would be the first specific therapy you receive for your cancer once it has spread.
Will I know if I'm getting the new drug or the placebo?
No, it's a 'blinded' study, meaning neither you nor your doctors will know which treatment you are receiving until the study is over, unless there's a medical need to find out.
What are 'standard-of-care' treatments?
These are treatments that are currently accepted as effective and commonly used for a specific condition, like FOLFOX chemotherapy and bevacizumab for bowel cancer.
How to find out more
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Always speak to your GP or specialist before deciding to take part in a study.
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