A Phase 3, Randomized, Open-label Study of Relatlimab-nivolumab Fixeddose Combination Versus Regorafenib or Trifluridine + Tipiracil (TAS-102) for Participants with Later-lines of Metastatic Colorectal Cancer
This research is looking at a new combination of medicines called relatlimab-nivolumab for people who have advanced bowel cancer (colorectal cancer) that has spread to other parts of the body. These people have already tried other treatments. The study aims to see if this new combination works better than two standard treatments currently given for this type of cancer: Lonsurf or Stivarga. Researchers will carefully check if people taking the new combination live longer and if their cancer stops growing for a longer time. They will also look at any side effects and how treatments affect people's quality of life. This is a large study (Phase 3), meaning it's a final step to see if the new treatment should become a standard option.
At a glance
What is this study about?
This study is for people who have advanced bowel cancer, also known as metastatic colorectal cancer. This means the cancer has spread from the bowel to other parts of the body. Participants in this study have already received earlier treatments for their cancer, but these treatments are no longer working as well as hoped.
The main goal of this study is to compare a new combination medicine, called relatlimab-nivolumab, with two established treatments for this type of advanced cancer: Lonsurf (trifluridine + tipiracil) or Stivarga (regorafenib). The researchers want to find out if the new combination can help people live longer overall and if it can keep the cancer from growing or spreading for a longer time. They are particularly interested in groups of patients with certain characteristics of their cancer cells.
Beyond how long people live, the study will also look at how many people respond to the treatments (meaning their tumours shrink or stop growing), how long that response lasts, and importantly, the side effects of each treatment. They will also carefully monitor how the treatments affect people's day-to-day lives and overall well-being, including their physical abilities and general quality of life. This information is crucial for understanding the full picture of how a new treatment might benefit patients.
Key takeaways
- This study compares a new drug combination with current standard treatments for advanced bowel cancer.
- It aims to see if the new combination can help people live longer and keep cancer from growing.
- Researchers will also track side effects and how treatment affects quality of life.
- Participants will undergo regular checks, scans, and receive study medication.
- Both men and women aged 18 and over with metastatic colorectal cancer may be eligible.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part.
There will be other important health requirements to make sure the study is safe and suitable for you. For example, your doctors will check your general health, how well your organs are working, and the specific details of your bowel cancer, including any previous treatments you've had.
The study team will carefully review all your medical information during a screening process to see if you meet all the necessary criteria to participate safely.
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 advanced bowel cancer (colorectal cancer that has spread)?
- Have you already received other treatments for your bowel cancer that are no longer fully working?
- Are you generally well enough to participate in a clinical trial?
What does participation involve?
If you join this study, you would be randomly assigned to receive either the new relatlimab-nivolumab combination or one of the standard treatments (Lonsurf or Stivarga). This is like tossing a coin, to ensure fairness and accurate comparison. You and your doctor would know which treatment you are receiving because it's an 'open-label' study.
Your participation would involve regular visits to the clinic for medical check-ups, blood tests, scans (like CT or MRI) to see how the cancer is responding, and to receive your study medication. You would also fill out questionnaires about how you are feeling and how the treatment is affecting your quality of life. The total duration of your participation would depend on how your cancer responds to the treatment, but you would have regular follow-up appointments even after treatment ends.
Potential risks and benefits
Locations (10)
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- —UnverifiedPoland
Common questions
What is 'advanced bowel cancer'?
Advanced bowel cancer means the cancer has spread from where it started in the bowel to other parts of the body.
What is the new medicine being tested?
The new medicine is a combination of two drugs called relatlimab and nivolumab.
Will I know which treatment I'm getting?
Yes, in this study, both you and your doctor will know whether you are receiving the new combination or the standard treatment.
What are 'Lonsurf' and 'Stivarga'?
Lonsurf and Stivarga are two established medicines that are already used to treat advanced bowel cancer.
How long will I be in the study?
The length of time you participate will depend on how you respond to the treatment, with regular follow-ups continuing once treatment finishes.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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