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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

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)

Study details

Head and Neck Squamous Cell Carcinoma

NCT06163534

Tempus AI

10 January 2025

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