This multicenter, randomized, double-blind Phase 2/3 study evaluates ficerafusp alfa (BCA101) in combination with pembrolizumab as first-line therapy in patients with PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The objective of the study is to assess the efficacy of the combination compared with placebo plus pembrolizumab. Eligible participants are adults with PD-L1-positive recurrent or metastatic HNSCC who have not received prior systemic therapy for advanced disease. PD-L1 status is determined prior to study enrollment. Participants are randomized to receive either ficerafusp alfa plus pembrolizumab or placebo plus pembrolizumab. Efficacy and safety outcomes are evaluated throughout the study.
This clinical study evaluates a new treatment approach for people with advanced head and neck cancer. The study tests the drug ficerafusp alfa (BCA101) in combination with the immunotherapy pembrolizumab. Adults with recurrent or metastatic head and neck squamous cell carcinoma whose tumors are positive for the PD-L1 protein and who have not received prior treatment for advanced disease may participate. The goal of the study is to determine whether adding ficerafusp alfa can improve the effectiveness of pembrolizumab. Participants are randomly assigned to one of two treatment groups. One group receives ficerafusp alfa together with pembrolizumab, while the other receives a placebo together with pembrolizumab.
