FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

To join this study, you must be at least 18 years old and have a confirmed diagnosis of head and neck cancer that has either returned or spread. This cancer must specifically be in your mouth, throat, or voice box. Your cancer cells also need to show a particular marker called PD-L1, which doctors will check from a tissue sample. You shouldn't have had any recent treatment for cancer that has spread or come back, and your general health and organ function need to be good enough for you to take part.

There are also some reasons why you might not be able to join. For example, if your cancer could be cured with local treatments like surgery or radiation, or if you've already had certain types of anti-cancer treatments that target EGFR or TGF-β. You also can't participate if you’ve had another immune treatment for cancer in the last six months, if your cancer has spread to your brain or spinal cord, or if you've recently had significant bleeding. The study also cannot accept you if your life expectancy is considered to be less than three months.

If you decide to take part, you'll be assigned to one of three treatment groups. Two groups will receive different doses of ficerafusp alfa along with pembrolizumab, while the third group will receive a placebo (dummy treatment) with pembrolizumab. You won't know which group you are in. Both ficerafusp alfa (or placebo) and pembrolizumab will be given as infusions (into a vein) at regular intervals – ficerafusp alfa/placebo weekly, and pembrolizumab every three weeks.

You will have regular hospital visits for treatments, health checks, blood tests, and scans to monitor your cancer and how you're responding to the treatment. These visits will also allow the study team to look for any side effects. The total length of your participation will depend on how you respond to the treatment and what the doctors decide, but it will involve continued treatment and follow-up until the treatment is no longer beneficial or side effects become too much. You can withdraw from the study at any time.