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

June 10, 2026 updated by: Tempus AI

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Active, not recruiting
        • Pan American Cancer for Oncology
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Ravi Salgia
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Contact:
        • Principal Investigator:
          • Deborah Wong
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC/Norris Comprehensive Cancer Center
        • Principal Investigator:
          • Jacob Thomas
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford
        • Principal Investigator:
          • Saad Khan
        • Contact:
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
        • Principal Investigator:
          • Ian Anderson
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute, Emory University
        • Principal Investigator:
          • Nabil Saba, MD
        • Contact:
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Piedmont Healthcare
        • Contact:
        • Principal Investigator:
          • Sope Olugbile
      • Atlanta, Georgia, United States, 30310
        • Recruiting
        • Morehouse
        • Principal Investigator:
          • Roland Matthews
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University Feinberg School of Medicine
        • Principal Investigator:
          • Jochen Lorch
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois
        • Principal Investigator:
          • James Wade
        • Contact:
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois Cancer Care
        • Principal Investigator:
          • Fahad Asad
        • Contact:
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas
        • Principal Investigator:
          • Prakash Neupane
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • University of Maryland
        • Principal Investigator:
          • Ranee Mehra
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Principal Investigator:
          • Robert Haddad
        • Contact:
    • Michigan
      • Detriot, Michigan, United States, 48202
        • Recruiting
        • Henry Ford
        • Contact:
        • Principal Investigator:
          • Matthew Wilkins
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Principal Investigator:
          • Ammar Sukari, MD
        • Contact:
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Oncology Hematology Associates
        • Contact:
        • Principal Investigator:
          • V. Roger Holden, MD, PHD
      • St Louis, Missouri, United States, 63130
        • Recruiting
        • Washington University in St. Louis
        • Principal Investigator:
          • Douglas Adkins, MD
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Kryzsztof Misiukiewicz
    • North Dakota
      • Fargo, North Dakota, United States, 58102
        • Recruiting
        • Sanford Fargo
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati
        • Principal Investigator:
          • Chris Lemmon, MD
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Shlomo Koyfman
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Principal Investigator:
          • Marcelo Bonomi
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Cancer Care Associates of York
        • Principal Investigator:
          • Chanh Huynh
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt University
        • Principal Investigator:
          • Jennifer Choe
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington
        • Contact:
        • Principal Investigator:
          • Cristinia Rodriguez
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare
        • Principal Investigator:
          • Matthias Weiss
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This protocol targets patients with metastatic or unresectable, recurrent HNSCC intended for first line immunotherapy or combination therapy.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Metastatic or unresectable recurrent HNSCC
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?

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.
Time Frame: 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.
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.
Time Frame: 5 years
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.
Time Frame: 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tempus AI

Collaborators

AstraZeneca

Investigators

  • Study Director: Virginia Rhodes, MD, Tempus AI, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-CA-006
  • Pro00074943 (Other Identifier: Advarra)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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