Phase 3 Study Comparing Ficlatuzumab Plus Cetuximab to Placebo Plus Cetuximab in Adults With Recurrent or Metastatic HPV-Negative Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the efficacy and safety of combining ficlatuzumab with cetuximab compared to cetuximab alone in people with recurrent or metastatic RM HPV-negative head and neck squamous cell carcinoma HNSCC. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants who have not responded to prior anti-PD-1PD-L1 immune checkpoint inhibitors and platinum-based chemotherapy. The goal is to see if adding ficlatuzumab improves survival outcomes in this patient group. Participants are assigned to one of three groups two groups receive different doses of intravenous ficlatuzumab plus cetuximab on days 1 and 15 of each 28-day cycle, while the third group receives a placebo plus cetuximab on the same schedule. The study will enroll about 410 participants and compare progression-free survival and overall survival among these groups. Treatment cycles continue until disease progression or other study endpoints. During the study, participants will undergo regular imaging scans CT or MRI to assess tumor response every 8 weeks during the first year, then every 12 weeks in years 2 and 3, and every 6 months thereafter. Researchers will monitor safety, quality of life, and immune responses, including antidrug antibodies. The study period spans approximately 44 months with ongoing evaluations from randomization until death or last response assessment.

A Study of Ficlatuzumab in Combination With Cetuximab in Participants With Recurrent or Metastatic (R/M) HPV Negative Head and Neck Squamous Cell Carcinoma