Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC
brief summary
This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC). The names of the study drugs used in this research study are: * ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein) * pembrolizumab (a type of monoclonal antibody)
detailed description
This open-label, non-randomized, phase 2 clinical trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck.
The U.S. Food and Drug Administration (FDA) has not approved ficerafusp alfa as treatment for resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck.
The FDA has approved pembrolizumab as treatment for resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck.
The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, tumor biopsies, and Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans.
It is expected that about 32 people will take part in this research study. Bicara Therapeutics is supporting this research study by providing an investigational supply of Ficerafusp alfa.
official title
Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable Squamous Cell Carcinoma of the Head and Neck: a Phase 2 Trial