NCT07465276

Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC

Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable Squamous Cell Carcinoma of the Head and Neck: a Phase 2 Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma (HNSCC)
• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Ficerafusp alfa	Bifunctional antibody and recombinant fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol.
DRUG	Pembrolizumab	Monoclonal antibody, single-dose vial, via intravenous infusion per protocol.

Timeline

• Start date: 2026-03-26
• Primary completion: 2028-04-30
• Completion: 2030-04-30
• First posted: 2026-03-11
• Last updated: 2026-03-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study