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

Study Overview
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Brief Summary
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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.

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

Conditions
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Head and Neck Squamous Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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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 fresh or archived block tumor 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metastatic or unresectable recurrent HNSCC<br>Up to 500 participants (including primary tumor location of pharynx, larynx, oral cavity and oropharynx) with metastatic or unresectable recurrent HNSCC who are intended for first line immunotherapy or combination therapy. No intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore DNA, RNA, immune and other multiomic biomarkers to better understand prognostic or predictive biomarkers and to inform future research for new relevant biomarkers. | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore changes in relevant DNA, RNA, immune and multiomic biomarkers in longitudinal blood samples, and diagnostic and progression biopsy samples, to understand real-world outcomes and resistance mechanisms. | Correlate biomarkers of collected blood and tissue samples with standard of care therapy real-world outcomes such as overall survival, progression free survival, time to next treatment, and time to treatment discontinuation. | 5 years | 
| Explore changes in ctDNA from longitudinal blood samples to assess ctDNA as a response biomarker. | Assess changes in ctNDA of collected blood samples using ctDNA clearance factors such as time to clearance, best overall clearance rate, best confirmed clearance, duration, time to ctDNA recurrence with standard of care therapy real-world outcomes such as overall survival, progression free survival, time to next treatment, and time to treatment discontinuation. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncology, Biomarkers, Genomic Profiling, HNSCC, Cancer, Observational, Registry, Precision Medicine, NGS