Long-Term Observational Study of Molecular Biomarkers in Adults with Head and Neck Squamous Cell Carcinoma Receiving First-Line Immunotherapy

What this Trial Is About

This research is a prospective, longitudinal, non-interventional, multicenter observational study focused on adults with metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma HNSCC. It aims to analyze tissue and blood molecular biomarker profiles during their standard first-line immunotherapy or combination therapy. The study is designed to explore DNA, RNA, immune, and other multiomic biomarkers to identify prognostic or predictive markers that may guide future research. Participants include up to 500 adults with tumors in the pharynx, larynx, oral cavity, or oropharynx who are receiving first-line anti-PD1 or PDL1 immunotherapy or combination treatments as part of routine care. There is no study intervention beyond standard treatment. Tumor tissue samples and longitudinal blood samples will be collected for molecular biomarker analysis over a 5-year period. During the study, participants will provide tumor tissue representative of their current disease and serial blood samples for biomarker evaluation. Researchers will assess changes in DNA, RNA, immune markers, and circulating tumor DNA ctDNA to understand disease progression, treatment response, and resistance mechanisms. The study will monitor participants for up to 5 years to collect data correlating biomarkers with real-world outcomes.

A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)