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

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

The study is a prospective, longitudinal, non-interventional, multicenter study of participants with HNSCC who will have tissue and blood based molecular biomarker profiling during their standard of care treatment.

Inclusion Criteria:

• ≥18 years of age
• Willing and able to provide informed consent
• Histologically- or cytologically-confirmed metastatic or unresectable, recurrent HNSCC unsuitable for local therapies
• Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy
• Must submit tumor tissue sample representative of current disease per laboratory manual

Exclusion Criteria:

• Non-squamous histologies (eg, nasopharynx or salivary gland)
• Relapse or recurrence within 6 months of first line chemotherapy and / or chemoradiotherapy
• Tumors that are PD-L1 negative (CPS <1)
• Clinical evidence of an active second invasive malignancy within <2 years of enrollment with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers
• Unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)