Phase 1b safety study of xevinapant, weekly cisplatin, and radiotherapy in participants with unresected LA SCCHN
This study is for people with advanced head and neck cancer that can't be removed by surgery. It's a early-stage study, meaning researchers are carefully checking if a new drug called xevinapant is safe when given alongside the usual weekly chemotherapy (cisplatin) and radiotherapy. They want to find the right dose and see if this combination causes any unexpected side effects. Because it's an early study, the main goal is to understand safety and how the new drug acts within the body. This information will help decide if this treatment could be helpful for future patients and move on to larger studies.
At a glance
What is this study about?
This research is focused on a type of cancer that starts in the head and neck area, specifically a kind called squamous cell carcinoma, which has grown to an advanced stage and can't be removed with an operation. Doctors are always looking for better ways to treat these cancers, and this study explores a new approach.
The study introduces a new drug called xevinapant. The idea is to combine this new drug with treatments that are already commonly used for this type of cancer: weekly chemotherapy (a drug called cisplatin) and radiotherapy (high-energy rays that kill cancer cells). The main aim is to carefully check if giving these three treatments together is safe for patients. Because this is a very early study (a 'Phase 1b' study), the primary goal is not to prove that the new drug cures cancer, but to understand its safety when combined with existing treatments and to work out the best dose to use. Researchers will be monitoring patients closely for any side effects.
Ultimately, the hope is that by understanding how safe this new drug combination is, researchers can gather important information. This information will help them decide if this treatment combination has the potential to be more effective than current approaches. If proven safe and promising in these early stages, it could lead to further research in larger groups of patients, potentially offering new treatment options in the future for people with this type of head and neck cancer.
Key takeaways
- This study is for advanced head and neck cancer.
- It tests a new drug (xevinapant) with standard chemotherapy and radiotherapy.
- The main goal is to check for safety and find the right drug dose.
- It's an early-stage study; benefits are not guaranteed.
- You will be closely monitored by doctors and nurses.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you would need to be an adult, at least 18 years old, and your gender doesn't matter – men and women can both take part. The study is specifically for people who have a certain type of head and neck cancer called 'squamous cell carcinoma' that has grown to an advanced stage in a local area and can't be removed by surgery.
There might be other health requirements or specific tests you need to have to make sure the study is safe and right for you. For example, doctors will check your overall health and how well your body systems are working. These are important steps to ensure that participating in the study is the best option for your health.
It's important to remember that the study team will review all your medical information carefully to see if you are a good fit for this particular research. Even if you meet the general age and cancer type criteria, there could be other reasons why you might not be able to participate, as patient safety is always the top priority.
- Are you 18 years old or older?
- Have you been diagnosed with advanced squamous cell carcinoma of the head and neck that can't be surgically removed?
- Are you able to receive weekly cisplatin chemotherapy and radiotherapy?
- Are you generally well enough to participate in a medical study?
- Are you willing to attend regular hospital appointments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would receive the new drug (xevinapant) along with standard weekly cisplatin chemotherapy and radiotherapy. You would have regular appointments at the hospital or clinic, which might include having blood tests, physical examinations, and scans to check on your health and how the treatment is working. The study team will explain the schedule of these visits in detail. You would be given instructions on how to take the medication, and there would be a follow-up period after your main treatment to monitor your progress and long-term health. The total time you would be involved in the study, including follow-up, would be fully explained before you agree to participate.
Potential risks and benefits
Locations (2)
- —Belgium
- —Spain
Common questions
What is xevinapant?
Xevinapant is a new drug being tested to see if it can help treat certain cancers when given alongside chemotherapy and radiotherapy.
What does 'Phase 1b study' mean?
It means this is an early stage of research. Doctors are mainly checking if the new treatment combination is safe for people and what the right dose should be, rather than how well it cures the cancer.
What is 'locally advanced squamous cell carcinoma of the head and neck'?
This is a type of cancer in the head or neck area that has grown but hasn't spread to distant parts of the body, and it can't be removed by surgery.
Will I definitely get better if I join this study?
Because this is an early safety study, we can't promise that you will get better. The main goal is to understand the safety of the new treatment, which might help future patients.
Can I stop participating in the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and it won't affect your regular medical care.
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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