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

About

Brief Summary

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.

Study Type

Observational

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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)

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