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A Randomized, Phase II Study of Ficlatuzumab with or without Cetuximab in Patients with Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Primary Objective: To assess the efficacy of ficlatuzumab, with or without concurrent cetuximab, in patients with cetuximab-resistant, recurrent/metastatic HNSCC as measured by Progression-Free Survival (PFS). Secondary Objective: To describe toxicity and patient-reported quality of life. - To evaluate response rate and overall survival in both treatment arms. - To evaluate the relationship between clinical outcomes (PFS, RR) and candidate tumoral, genomic, peripheral, and immune biomarkers, including: HGF/cMet, EGFR/EGFR, and EGFR/HER2 dimers; mutations in PIK3CA, PTEN, and HRAS; peripheral serum biomarkers including VeriStrat, HGF, soluble HGF, and IL6; peripheral lymphocyte populations; archived and baseline immune infiltrate.