A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC).
This research study is for people with a type of advanced bowel cancer called Microsatellite Stable (MSS) Colorectal Cancer, where the cancer has spread. Researchers are testing a new medicine called Denikitug, both on its own and in combination with other existing cancer treatments like Lonsurf, Avastin, and Opdivo. The main goal is to find out how effective these treatments are at shrinking the cancer or stopping it from growing, and to understand any side effects. This is a Phase 2 study, meaning it's exploring how well the treatments work and their general safety before potentially moving to larger studies. All participants will be 18 years or older, and both men and women can take part.
At a glance
What is this study about?
This research study is investigating new ways to treat advanced bowel cancer, specifically a type known as Microsatellite Stable (MSS) Colorectal Cancer, which means the cancer has spread. When we say 'advanced,' it means the cancer has grown beyond its original site and might be harder to treat with standard methods. This study is testing a new medicine called Denikitug.
Researchers want to see if Denikitug, taken on its own, or combined with other approved cancer drugs like Lonsurf, Avastin, and Opdivo, can help people with this condition. They are looking closely at how effective these treatments are at reducing the size of the cancer or stopping it from growing, and importantly, they are also monitoring for any side effects to understand how safe the treatments are.
This is called a 'Phase 2' study. This phase usually involves a smaller number of people than later stages. The main purpose of a Phase 2 study is to explore how well a new treatment works, find the right dose, and get a better understanding of its safety, before potentially moving on to larger studies involving many more patients.
Key takeaways
- Tests a new treatment, Denikitug, for advanced bowel cancer that has spread.
- Compares Denikitug alone and with other standard cancer medicines.
- Aims to understand how well the treatments work and their potential side effects.
- Open to adults (18+) with a specific type of advanced bowel cancer (MSS CRC).
- Participation involves regular visits, tests, and closely monitored treatment.
- It's a Phase 2 study – an important step in developing new treatments.
Who may be eligible?
To join this study, people generally need to be 18 years old or older. The study is open to both men and women.
Crucially, participants must have a specific type of advanced bowel cancer called Microsatellite Stable (MSS) Colorectal Cancer, where the cancer has spread to other parts of the body.
While the main criteria are your age and the specific type of advanced bowel cancer, there will also be other health checks and medical requirements to make sure the study treatments are suitable and safe for you. Your doctor will discuss all these in detail.
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 that has spread?
- Has your doctor confirmed your cancer is 'Microsatellite Stable (MSS)' type?
- Are you willing to have regular hospital visits, including tests and scans?
- Have you discussed this trial with your specialist doctor?
What does participation involve?
If you decide to take part, you would receive one of the study treatments, which could be Denikitug alone or Denikitug combined with other medicines like Lonsurf, Avastin, or Opdivo. These will be given as injections into a vein (infusions) or as tablets, depending on the specific treatment plan you are assigned.
You would have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. Doctors will carefully track any changes in the size of your cancer and any side effects you might experience. They will also look at how the study drugs are processed by your body. The total duration of your participation and the exact schedule of visits will be explained by your study team.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedItaly
Common questions
What kind of cancer is this study for?
This study is for advanced bowel cancer (Colorectal Cancer) that is specifically of the 'Microsatellite Stable (MSS)' type, meaning the cancer has spread.
What treatments are being tested?
The study is testing a new medicine called Denikitug, both by itself and in combination with other existing cancer drugs like Lonsurf, Avastin, and Opdivo.
What are researchers hoping to find out?
They want to know how effective these treatments are at shrinking the cancer or stopping its growth, and to understand any side effects to see how safe they are.
Who can take part in this study?
Adults aged 18 and over, both men and women, with the specific type of advanced bowel cancer mentioned previously, can potentially take part.
What does a 'Phase 2' study mean?
Phase 2 studies are early-stage trials that explore how well a new treatment works and gather more information about its safety in a smaller group of people.
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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