Immunotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.
Ronan W Hsieh, Steven Borson, Anastasia Tsagianni...
https://pubmed.ncbi.nlm.nih.gov/34540672Actively Recruiting
Age: 18Years +
All Genders
ID06163534
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
Age: 18Years +
All Genders
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Monitoring
Duration - Up to 5 years
Participants undergoing first line immunotherapy or combination therapy are observed with longitudinal collection of blood and biopsy samples to explore multi-omic biomarkers and understand treatment response and resistance mechanisms.
Periodic blood and biopsy sample collections over 5 years
Trial Site Locations
Total: 30 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
4
Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
5
Providence Medical Foundation
Santa Rosa, California, United States, 95403
Actively Recruiting
6
Morehouse
Atlanta, Georgia, United States, 30310
Actively Recruiting
7
Piedmont Healthcare
Atlanta, Georgia, United States, 30318
Actively Recruiting
8
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
9
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
10
Cancer Care Specialists of Illinois
Decatur, Illinois, United States, 62526
Actively Recruiting
11
Illinois Cancer Care
Peoria, Illinois, United States, 61615
Actively Recruiting
12
University of Kansas
Westwood, Kansas, United States, 66205
Actively Recruiting
13
University of Maryland
Baltimore, Maryland, United States, 21202
Actively Recruiting
14
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
15
Henry Ford
Detriot, Michigan, United States, 48202
Actively Recruiting
16
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
17
Oncology Hematology Associates
Springfield, Missouri, United States, 65807
Actively Recruiting
18
Washington University in St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
19
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
20
Sanford Fargo
Fargo, North Dakota, United States, 58102
Actively Recruiting
21
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
22
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
23
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
24
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
25
Cancer Care Associates of York
York, Pennsylvania, United States, 17403
Actively Recruiting
26
Sanford Sioux Falls
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
27
Vanderbilt University
Nashville, Tennessee, United States, 37212
Actively Recruiting
28
University of Washington
Seattle, Washington, United States, 98109
Actively Recruiting
29
ThedaCare
Appleton, Wisconsin, United States, 54911
Actively Recruiting
30
Pan American Cancer for Oncology
San Juan, Puerto Rico, 00909
Active, Not Recruiting
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Research Team
P
Phoenix HNSCC
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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