Actively Recruiting
TEMPUS PHOENIX HNSCC STUDY A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head Neck Squamous Cell Carcinoma HNSCC
Led by Tempus AI · Updated on 2026-04-06
500
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Tempus AI
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, longitudinal, non-interventional study involving participants with metastatic or unresectable recurrent head and neck squamous cell carcinoma HNSCC. The study focuses on molecular biomarker profiling using tissue and blood samples collected during participants standard care treatment, aiming to enhance understanding of prognostic and predictive biomarkers over a five-year period. Participants planned for first-line immunotherapy or combination therapy will be included, with no additional interventions applied by the study. Up to 500 participants with tumors located in the pharynx, larynx, oral cavity, or oropharynx will be observed. Tissue samples representative of current disease and longitudinal blood samples will be collected to analyze DNA, RNA, immune, and other multiomic biomarkers. Throughout the study, participants will undergo biomarker assessments from blood and tumor tissue collected at diagnosis and progression. Researchers will explore changes in circulating tumor DNA ctDNA and other biomarkers to understand treatment responses and resistance mechanisms. The study will last up to five years, focusing on real-world outcomes and biomarker evolution during routine care without altering treatment plans.
CONDITIONS
Brief Title
A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Willing and able to provide informed consent
- Histologically or cytologically confirmed metastatic or unresectable recurrent head and neck squamous cell carcinoma not suitable for local therapies
- Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy
- Must submit a tumor tissue sample representative of current disease according to laboratory manual
You will not qualify if you...
- Non-squamous histologies such as nasopharynx or salivary gland cancers
- Relapse or recurrence within 6 months after first line chemotherapy and/or chemoradiotherapy
- Tumors that are PD-L1 negative with a combined positive score (CPS) less than 1
- Active second invasive malignancy within less than 2 years of enrollment, except stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma, or localized non-melanoma skin cancers
- Unable or unwilling to comply with study procedures, including additional blood sample collections
Research Team
P
Phoenix HNSCC
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