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Observational Study for Head & Neck Squamous Cell Carcinoma Biomarkers

This study is looking at people with head and neck squamous cell carcinoma (HNSCC) that has spread or come back and cannot be treated with local therapies. You would be eligible if you are planning to receive anti-PD1 or PDL1 monotherapy or combination therapy as your first treatment. Researchers will collect tissue and blood samples during your regular care to look for specific markers (biomarkers) like PD-L1. The goal is to better understand these biomarkers and how they might predict how well treatments work or how the disease progresses, which could help in developing future treatments. The study aims to enroll about 500 participants and will follow them for 5 years.

Study design
This is an observational study, meaning you will receive standard medical care while researchers collect information. It plans to include about 500 participants.
What's involved
You would provide tumor tissue and blood samples during your standard medical care. The study will follow you for 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years to explore various biomarkers.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06163534

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

Recruiting
Not specifiedAges 18+Observational
Tempus AI
~500 participants
Updated 2026-06-12 on ClinicalTrials.gov

At a glance

Recruiting sites
29 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers.
Measured over 5 years

Conditions

Head and Neck Squamous Cell Carcinoma

Explore related trials

Head and Neck Squamous Cell CarcinomaProgrammed Cell Death 1 Ligand 1

Where it's being run

30 sites across 17 states
California5
Georgia3
Illinois3
Ohio3
Michigan2
Missouri2
Pennsylvania2
Kansas1

Study leadership

  • Virginia Rhodes, MD · STUDY_DIRECTOR · Tempus AI, Inc.

Who to contact

Phoenix HNSCC
[email protected]
(833) 514-4187
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥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

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)

What this trial measures

  • Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers.5 years

    Use NGS, ctNDA assessments, RNA analysis, and other multiomic testing to uncover biomarkers of collected blood and tissue samples that may predict outcomes, identify markers related to disease, identify markers related to mechanism of drug action, and inform future research.