Study of Ficerafusp Alfa with Pembrolizumab Compared to Placebo with Pembrolizumab in First-Line Treatment of PD-L1-Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab for adults with first-line PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma. This study focuses on the dual targeting of EGFR and TGF-beta, which contribute to tumor growth and spread. It includes both phase 2 and phase 3 parts to identify the best dose and to compare treatment outcomes. In phase 2, participants are randomized into three groups receiving either higher or lower doses of ficerafusp alfa plus pembrolizumab, or placebo plus pembrolizumab. In phase 3, participants receive the selected optimal biologic dose of ficerafusp alfa with pembrolizumab or placebo with pembrolizumab in a 21 ratio. Treatments are given weekly or every three weeks depending on the drug, with careful monitoring throughout the study. Participants will undergo tumor biopsies or provide archival tissue, and receive regular assessments including imaging scans and lab tests to measure tumor response and safety. Researchers will track side effects, response rates, survival, and quality of life using standardized criteria over approximately 1 to 3 years. Safety monitoring continues up to 90 days after treatment ends. The total study duration extends through long-term follow-up to evaluate overall outcomes.

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