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Longitudinal biomarker profiling for patients with head and neck cancer

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

Observational Tempus AI · NCT06163534

This study is trying to see how the molecular makeup of head and neck cancer changes over time in patients who are receiving first-line anti-PD1 or PDL1 therapy.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorTempus AI Industry-sponsored
Drugs / interventionschemotherapy
Locations30 sites (Duarte, California and 29 other locations)
Trial IDNCT06163534 on ClinicalTrials.gov

What this trial studies

This observational study involves the collection of tissue and blood samples from patients with head and neck squamous cell carcinoma (HNSCC) during their standard treatment. It aims to perform multi-omic biomarker profiling to better understand the molecular characteristics of the disease. Participants will be monitored over time to assess changes in their biomarker profiles as they undergo treatment. The study is non-interventional and focuses on patients who are unsuitable for local therapies and are intended for first-line anti-PD1 or PDL1 therapy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed metastatic or unresectable recurrent HNSCC who are eligible for first-line anti-PD1 or PDL1 therapy.

Not a fit: Patients with non-squamous histologies or those with PD-L1 negative tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved personalized treatment strategies for patients with HNSCC based on their unique biomarker profiles.

How similar studies have performed: Other studies have shown promise in using biomarker profiling to tailor cancer treatments, indicating that this approach has potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Duarte, California and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Head and Neck Squamous Cell CarcinomaOncologyBiomarkersGenomic ProfilingHNSCCCancerObservationalRegistry
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.