Multicenter, open-label, randomized Phase 2 study evaluating continuous weekly dosing of ficerafusp alfa (BCA101) in combination with pembrolizumab versus an alternative dosing regimen for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma
This Phase 2 clinical trial is studying a new treatment for adults with head and neck cancer that has come back (recurrent) or spread to other areas of the body (metastatic). It is designed for people who have not yet had treatment for this advanced stage of cancer. The trial tests an experimental medicine named ficerafusp alfa given alongside pembrolizumab, an approved immunotherapy that helps the immune system attack cancer cells. Researchers want to compare two different dosing schedules of ficerafusp alfa to see which one works better and causes fewer side effects. The main goal is to find out if the treatment stops tumours from growing or shrinks them, while checking how safe the combination is. Taking part involves regular visits to a hospital clinic for treatment through a drip, health checks, and routine scans to monitor progress.
At a glance
What is this study about?
Head and neck cancer starts in areas like the mouth, throat, or voice box. When this type of cancer comes back after initial treatment or spreads to other parts of the body, doctors need effective treatments to help control the disease, ease symptoms, and help people live longer.
This trial investigates a new drug called ficerafusp alfa (also known as BCA101). It is designed to block specific signals that cancer cells use to grow and hide from the body's defences. In this study, it is combined with pembrolizumab (Keytruda), a widely used immunotherapy drug that helps the patient's own immune system find and destroy cancer cells.
Participants are placed into different treatment groups to compare giving ficerafusp alfa continuously every week against an alternative dosing schedule. By comparing these schedules, doctors hope to discover the most effective way to give the medicine with the fewest side effects, giving future patients the best possible balance of benefit and quality of life.
Key takeaways
- Phase 2 clinical trial for adults with recurrent or metastatic head and neck cancer.
- Tests a new medicine, ficerafusp alfa, combined with the immunotherapy drug pembrolizumab.
- Compares two dosing schedules to find the safest and most effective way to give the treatment.
- Both treatments are given as drips into a vein at regular hospital visits.
- Participation is voluntary, and you are monitored closely by specialist doctors throughout.
Who may be eligible?
This trial is open to adults aged 18 and older who have squamous cell carcinoma of the head and neck. To take part, the cancer must have either returned after previous treatment or spread to other parts of the body, and you must not have received prior drug treatment for this advanced stage.
Both men and women can join. Your general health must be stable enough to safely receive immunotherapy and attend regular hospital appointments. Your hospital care team will check your medical history, kidney and liver function, and heart health to make sure the trial is suitable for you.
People who have had certain previous treatments, or who have specific active medical conditions such as serious autoimmune illnesses, may not be able to join. The study team will review all your records to ensure taking part is safe.
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.
- I am aged 18 or older.
- I have been diagnosed with squamous cell carcinoma of the head and neck.
- My cancer has come back (recurrent) or spread to other parts of my body (metastatic).
- I have not yet started first-line drug therapy for this advanced stage of cancer.
- I am well enough to attend regular clinic appointments and have hospital scans.
What does participation involve?
If you take part, you will receive both medicines as an infusion (a slow drip into a vein) at a specialised hospital clinic. Pembrolizumab is given every few weeks, while ficerafusp alfa is given on a regular schedule, such as once a week, depending on your assigned group. You will need regular clinic visits for blood tests, physical examinations, and scans (such as CT or MRI scans) every few weeks to monitor your tumour. Treatment usually continues for as long as the cancer remains stable and you do not experience troublesome side effects. You can choose to leave the study at any time without it affecting your standard NHS care.
Potential risks and benefits
Locations (1)
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Common questions
What is the purpose of this clinical trial?
The study tests whether combining a new drug called ficerafusp alfa with an established immunotherapy helps control advanced head and neck cancer, and compares two different dosing schedules.
How is the treatment given?
Both medicines are given directly into a vein through a drip (infusion) during scheduled hospital clinic visits.
Will I receive a dummy drug (placebo)?
No, this trial is open-label. Every participant receives active treatment with both pembrolizumab and ficerafusp alfa.
Can I leave the trial if I change my mind?
Yes. Taking part is entirely voluntary, and you can withdraw at any time without giving a reason and without your normal medical care being affected.
Will taking part cost me anything?
The trial drugs and study-related tests are provided free of charge, and trial sites often offer help with travel expenses.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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