A PHASE 2 STUDY OF ALX148 IN COMBINATION WITH PEMBROLIZUMAB AND CHEMOTHERAPY IN PATIENTS WITH ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA (ASPEN-04)
This study is looking into a new way to treat advanced head and neck cancer that has spread or come back. It involves giving patients a new drug called ALX148 alongside two established treatments: pembrolizumab (also known as Keytruda) and chemotherapy (5FU and platinum). The main goal is to find out how many patients respond to this new combination, meaning their tumours shrink or stop growing. Researchers will also be checking how long this improvement lasts, how patients feel during the treatment, and if there are any side effects. Your age needs to be 18 or over to take part, and both men and women can join. This is a Phase II study, which means it's testing whether the new combination is safe and effective enough to move on to larger studies.
At a glance
What is this study about?
This study is called ASPEN-04, and its main purpose is to explore a new way to treat a type of cancer that starts in the head and neck area. This specific cancer is called squamous cell carcinoma, and the study focuses on cases that have spread to other parts of the body (metastatic) or have returned after previous treatment (recurrent) and cannot be removed by surgery (unresectable). We understand that facing a diagnosis like this can be worrying, and studies like ours are continually working to find better treatments.
The research is testing a combination of three different types of medicine. One is a new, investigational drug called ALX148. This is being given together with pembrolizumab, which is a treatment already approved for some cancers and helps your immune system fight cancer. The third part of the combination is standard chemotherapy, which uses strong drugs to kill cancer cells throughout the body.
Researchers want to see if this new combination is more effective at shrinking tumours than existing treatments. They will also be carefully monitoring how the treatment affects patients' overall health, how long any positive effects last, and what side effects might occur. Your healthcare team will explain all the details if you are invited to consider participating.
Key takeaways
- This study tests a new three-drug combination for advanced head and neck cancer.
- It combines an experimental drug (ALX148) with existing immune therapy (pembrolizumab) and chemotherapy.
- The main aim is to see how effectively the combination shrinks tumours and improves patient outcomes.
- Participation involves regular clinic visits for treatments, tests, and monitoring.
- Both potential benefits (new treatment option) and risks (side effects) will be discussed thoroughly.
- You can stop participating at any time without affecting your future medical care.
Who may be eligible?
In general, this study is looking for adults aged 18 or older who have been diagnosed with a specific type of head and neck cancer. This cancer must either have spread to other parts of the body (called 'metastatic'), or it must have come back after previous treatment and cannot be removed with surgery ('recurrent and unresectable'). The study welcomes both men and women.
There will be other important health checks that your doctor will need to complete to make sure this study is right for you and that you can safely receive the treatments. These might include blood tests, information about your general health, and details about any other medical conditions you have. These checks are put in place to protect your safety and ensure the results of the study are clear and accurate.
- Are you 18 years old or older?
- Do you have advanced head and neck squamous cell carcinoma that has spread or returned?
- Has your doctor told you that your cancer cannot be removed by surgery?
- Are you generally well enough to receive combination treatments?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you would receive the investigational drug ALX148, along with pembrolizumab (Keytruda), and chemotherapy (5FU and platinum). All these medicines are given as infusions, meaning they are delivered directly into your bloodstream, usually through a drip.
You would have regular visits to the clinic for your treatments and for various tests. These tests are important to see how the treatment is working and to monitor your health. They might include blood tests, scans (like CT or MRI scans) to check the size of your tumours, and physical examinations. Researchers will also ask about any side effects you might be experiencing.
The total length of your participation would depend on how your cancer responds to the treatment and your overall health. You would continue to receive treatment for as long as it is helping you and you are tolerating it well. Even after you stop treatment, you would likely have follow-up visits to monitor your health and long-term well-being. Your study doctor will explain the full schedule of visits and procedures in detail.
Potential risks and benefits
Locations (3)
- —Belgium
- —Netherlands
- —Spain
Common questions
What kind of cancer is this study for?
This study is for a specific type of head and neck cancer called squamous cell carcinoma, especially if it has spread or come back and can't be removed by surgery.
What medicines will I receive?
You will get a new drug called ALX148, along with pembrolizumab (Keytruda) and chemotherapy (5FU and platinum).
What is the main goal of the study?
The main goal is to see how many patients respond to this new combination, meaning their tumours shrink or stop growing.
How long will I be in the study?
The length of your participation depends on how well the treatment works for you and your health. You will continue as long as it's helping and you're feeling well enough.
Will there be side effects?
Yes, like all medicines, the study drugs can have side effects. The study team will closely monitor you and treat any side effects that occur.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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