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

ID#: NCT06163534

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: August 01, 2024

End Date: March 01, 2028

Contact Information:
Phoenix HNSCC
(833) 514-4187
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.
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)
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