AzTrials
AzTrials

Head and Neck Squamous Cell CarcinomaNCT06163534

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

An observational study of Head and Neck Squamous Cell Carcinoma, run by Tempus AI at 32 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
Type of treatment
Pill or oral medicine
How many people
500 participants
Where
32 sitesin 2 countries
Study dates
1 Aug 2024to 1 Mar 2028
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • ≥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

Who cannot join

  • 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)

Trial locations and contacts

32 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Phoenix HNSCC contact

(833) 514-4187

phoenix@tempus.com

32 sites in 2 countries

United States31 sites, 31 recruiting

  • ThedaCare

    Appleton, Wisconsin, 54911

    Sarah Loether, 920-364-3604, sarah.loether@thedacare.org

    Matthias Weiss

    Recruiting

  • Morehouse

    Atlanta, Georgia, 30310

    Jessica Williams, 404-789-3826, jrwilliams@msm.edu

    Roland Matthews

    Recruiting

  • Piedmont Healthcare

    Atlanta, Georgia, 30318

    Dionne Jean, 404-425-7927, Dionne.Jean@piedmont.org

    Sope Olugbile

    Recruiting

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

    Johana Cruz, 404-686-3925, johana.cruz@emory.edu

    Nabil Saba, MD

    Recruiting

  • University of Maryland

    Baltimore, Maryland, 21202

    Rehan Khan, 410-328-7496, Rehan.Khan@umm.edu

    Ranee Mehra

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Sage Yenari, 617-632-8039, sage_yenari@dfci.harvard.edu

    Robert Haddad

    Recruiting

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

    Genesis Chase, 312-695-1519, genesis.chase@northwestern.edu

    Jochen Lorch

    Recruiting

  • University of Cincinnati

    Cincinnati, Ohio, 45219

    Shelby Mitchell, 513-584-6195, mitchesb@ucmail.uc.edu

    Chris Lemmon, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Alfred Kotarja, 216-442-1947, kotarja@ccf.org

    Shlomo Koyfman

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Harley Hamilton, 614-293-6522, Harley.Hamilton@osumc.edu

    Marcelo Bonomi

    Recruiting

  • Cancer Care Specialists of Illinois

    Decatur, Illinois, 62526

    Kaitlynn Kapp, 618-589-9721, kkapp@ccsci.net

    James Wade

    Recruiting

  • Henry Ford

    Detriot, Michigan, 48202

    Molly Constantino, mcostan3@hfhs.org

    Matthew Wilkins

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Walid Sukari, sukkarim@karmanos.org

    Ammar Sukari, MD

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Angelica Hamilton, 626-218-0109, ahamilton@coh.org

    Ravi Salgia

    Recruiting

  • Sanford Fargo

    Fargo, North Dakota, 58102

    Signe Harris, 701-234-7515, signe.harris@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Jared Frisch, 904-953-8903, Frisch.Jared@mayo.edu

    Yujie Zhao, MD, PhD

    Recruiting

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Sandy Tran, sandy.tran@med.usc.edu

    Jacob Thomas

    Recruiting

  • University of California, Los Angeles

    Los Angeles, California, 90095

    Youstina Zaki, 310-794-4955, YZaki@mednet.ucla.edu

    Deborah Wong

    Recruiting

  • Vanderbilt University

    Nashville, Tennessee, 37212

    Ilyana Ilieva, 615-936-0960, ilyana.ilieva@vumc.org

    Jennifer Choe

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Julia Miller, 212-824-5378, julia.miller@mssm.edu

    Kryzsztof Misiukiewicz

    Recruiting

  • Stanford

    Palo Alto, California, 94304

    Savanna Biedermann, 650-497-7418, savannab@stanford.edu

    Saad Khan

    Recruiting

  • Illinois Cancer Care

    Peoria, Illinois, 61615

    Emilie Nkangu, 309-243-3663, enkangu@illinoiscancercare.com

    Fahad Asad

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Daniel Huth, 541-778-0331, Daniel.Huth@PennMedicine.upenn.edu

    Lova Sun

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Jordan Meyers, 507-284-2030, Meyers.Jordan2@mayo.edu

    Patrick McGarrah, MD

    Recruiting

  • Providence Medical Foundation

    Santa Rosa, California, 95403

    Davina Montelongo, 707-521-3830 ext. 1180, Davina.Montelongo@providence.org

    Ian Anderson

    Recruiting

  • University of Washington

    Seattle, Washington, 98109

    Marcus Schoenfeld, 206-606-7487, msschoen@fredhutch.org

    Cristinia Rodriguez

    Recruiting

  • Sanford Sioux Falls

    Sioux Falls, South Dakota, 57104

    Brenna Many Horses, 605-312-6217, Brenna.Manyhorses@SanfordHealth.org

    Steven Powell

    Recruiting

  • Oncology Hematology Associates

    Springfield, Missouri, 65807

    Adrianna Moore, 417-882-4880, adrianna.moore@aoncology.com

    V. Roger Holden, MD, PHD

    Recruiting

  • Washington University in St. Louis

    St Louis, Missouri, 63130

    Samuel Williams, 314-747-2626, wsamuel@wustl.edu

    Douglas Adkins, MD

    Recruiting

  • University of Kansas

    Westwood, Kansas, 66205

    Emmanuel Mado, 913-945-9429, emadu@kumc.edu

    Prakash Neupane

    Recruiting

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

    Clarissa Vega, cvega@cancercareyork.com

    Chanh Huynh

    Recruiting

Other trials in United States

Puerto Rico1 site

  • Pan American Cancer for Oncology

    San Juan, 00909

    Active, not recruiting

Other trials in Puerto Rico

About this study

Official title: 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.

Keywords
Oncology, Biomarkers, Genomic Profiling, HNSCC, Cancer, Observational, Registry, Precision Medicine, NGS
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06163534
Study groupRoleWhat they receive
Metastatic or unresectable recurrent HNSCCUp 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 years

Secondary outcomes (2)

  1. 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.

    Measured: 5 years

  2. 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2023
  2. Study start1 Aug 2024
  3. Primary completion1 Mar 2028 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06163534
Sponsor's protocol ID
TP-CA-006
Other IDs
Pro00074943
Status last verified
Aug 2026
First submitted
7 Nov 2023
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hsieh RW, Borson S, Tsagianni A, Zandberg DP. Immunotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck. Front Oncol. 2021 Sep 1;11:705614. doi: 10.3389/fonc.2021.705614. eCollection 2021.

    PubMed 34540672

  • Head and neck cancer - risk factors and prevention. Cancer.Net. Published June 25, 2012. Accessed August 11, 2023. https://www.cancer.net/cancer-types/head-and-neck-cancer/risk-factors-and-prevention

  • Kimple RJ, Harari PM. The prognostic value of HPV in head and neck cancer patients undergoing postoperative chemoradiotherapy. Ann Transl Med. 2015 May;3(Suppl 1):S14. doi: 10.3978/j.issn.2305-5839.2015.01.37. No abstract available.

    PubMed 26046059

  • Ionna F, Bossi P, Guida A, Alberti A, Muto P, Salzano G, Ottaiano A, Maglitto F, Leopardo D, De Felice M, Longo F, Tafuto S, Della Vittoria Scarpati G, Perri F. Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: A Big and Intriguing Challenge Which May Be Resolved by Integrated Treatments Combining Locoregional and Systemic Therapies. Cancers (Basel). 2021 May 14;13(10):2371. doi: 10.3390/cancers13102371.

    PubMed 34069092

  • Samra B, Tam E, Baseri B, Shapira I. Checkpoint inhibitors in head and neck cancer: current knowledge and perspectives. J Investig Med. 2018 Oct;66(7):1023-1030. doi: 10.1136/jim-2018-000743. Epub 2018 Jun 25.

    PubMed 29941547

  • Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, Erfan J, Zabolotnyy D, Kienzer HR, Cupissol D, Peyrade F, Benasso M, Vynnychenko I, De Raucourt D, Bokemeyer C, Schueler A, Amellal N, Hitt R. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med. 2008 Sep 11;359(11):1116-27. doi: 10.1056/NEJMoa0802656.

    PubMed 18784101

  • Burtness B, Harrington KJ, Greil R, Soulieres D, Tahara M, de Castro G Jr, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak WZ, Hong RL, Gonzalez Mendoza R, Roy A, Zhang Y, Gumuscu B, Cheng JD, Jin F, Rischin D; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019 Nov 23;394(10212):1915-1928. doi: 10.1016/S0140-6736(19)32591-7. Epub 2019 Nov 1.

    PubMed 31679945

  • Wang HC, Yeh TJ, Chan LP, Hsu CM, Cho SF. Exploration of Feasible Immune Biomarkers for Immune Checkpoint Inhibitors in Head and Neck Squamous Cell Carcinoma Treatment in Real World Clinical Practice. Int J Mol Sci. 2020 Oct 15;21(20):7621. doi: 10.3390/ijms21207621.

    PubMed 33076306

  • Wei SC, Duffy CR, Allison JP. Fundamental Mechanisms of Immune Checkpoint Blockade Therapy. Cancer Discov. 2018 Sep;8(9):1069-1086. doi: 10.1158/2159-8290.CD-18-0367. Epub 2018 Aug 16.

    PubMed 30115704

  • Darvin P, Toor SM, Sasidharan Nair V, Elkord E. Immune checkpoint inhibitors: recent progress and potential biomarkers. Exp Mol Med. 2018 Dec 13;50(12):1-11. doi: 10.1038/s12276-018-0191-1.

    PubMed 30546008

  • Yu C, Li Q, Zhang Y, Wen ZF, Dong H, Mou Y. Current status and perspective of tumor immunotherapy for head and neck squamous cell carcinoma. Front Cell Dev Biol. 2022 Aug 26;10:941750. doi: 10.3389/fcell.2022.941750. eCollection 2022.

    PubMed 36092724

  • Kong L, Birkeland AC. Liquid Biopsies in Head and Neck Cancer: Current State and Future Challenges. Cancers (Basel). 2021 Apr 14;13(8):1874. doi: 10.3390/cancers13081874.

    PubMed 33919778

  • Mazurek AM, Rutkowski T, Fiszer-Kierzkowska A, Malusecka E, Skladowski K. Assessment of the total cfDNA and HPV16/18 detection in plasma samples of head and neck squamous cell carcinoma patients. Oral Oncol. 2016 Mar;54:36-41. doi: 10.1016/j.oraloncology.2015.12.002. Epub 2016 Jan 11.

    PubMed 26786940

  • Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

    PubMed 24553385

  • Wang Y, Springer S, Mulvey CL, Silliman N, Schaefer J, Sausen M, James N, Rettig EM, Guo T, Pickering CR, Bishop JA, Chung CH, Califano JA, Eisele DW, Fakhry C, Gourin CG, Ha PK, Kang H, Kiess A, Koch WM, Myers JN, Quon H, Richmon JD, Sidransky D, Tufano RP, Westra WH, Bettegowda C, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Agrawal N. Detection of somatic mutations and HPV in the saliva and plasma of patients with head and neck squamous cell carcinomas. Sci Transl Med. 2015 Jun 24;7(293):293ra104. doi: 10.1126/scitranslmed.aaa8507.

    PubMed 26109104

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Squamous Cell Carcinoma, run by Tempus AI at 32 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Phoenix HNSCC ((833) 514-4187, phoenix@tempus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06163534, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in