A Phase 2-3 Study of Ficerafusp Alfa or Placebo Plus Pembrolizumab in People with Advanced Head and Neck Cancer

Full Title

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Purpose

Researchers want to see if ficerafusp alfa plus pembrolizumab is safe and works well against head and neck cancer. They will assess different doses of ficerafusp alfa to find the best one. The people in this study have head and neck squamous cell carcinoma. Their cancers have come back or metastasized (spread) after treatment.

The researchers will also compare ficerafusp alfa plus pembrolizumab with the combination of placebo and pembrolizumab. The placebo looks like ficerafusp alfa but contains no medication.

Ficerafusp alfa targets and blocks the EGFR protein, which plays a role in cancer growth. The drug also works on a protein called TGF-beta. Tumor cells can develop ways to overpower TGF-beta regulation of cell growth and death, and they keep multiplying. Ficerafusp alfa can interrupt this process.

Pembrolizumab is an immunotherapy. It takes the brakes off the immune response so the immune system can find and kill cancer cells.

Both drugs are given intravenously (by vein). If you take part in this study, you will be randomly assigned to get one of these treatments:

• A higher dose of ficerafusp alfa in combination with the standard dose of pembrolizumab.
• A lower dose of ficerafusp alfa in combination with the standard dose of pembrolizumab.
• Placebo with the standard dose of pembrolizumab.

Who Can Join

To join this study, there are a few conditions. You must:

• Have head and neck squamous cell carcinoma that came back or metastasized after treatment.
• Have not had prior treatment for advanced head and neck cancer.
• Have a tumor that makes PD-L1 and is negative for human papillomavirus (HPV).
• Have recovered from the serious side effects of previous therapies before getting the study treatment.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Eric Sherman’s office at 646-608-3776.