Status:
RECRUITING
A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)
Lead Sponsor:
Tempus AI
Collaborating Sponsors:
AstraZeneca
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Brief 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 c...
Eligibility Criteria
Inclusion
- ≥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
- 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)
Key Trial Info
Start Date :
August 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06163534
Start Date
August 1 2024
End Date
March 1 2028
Last Update
December 8 2025
Active Locations (29)
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1
City of Hope
Duarte, California, United States, 91010
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
University of California, Los Angeles
Los Angeles, California, United States, 90095
4
Stanford
Palo Alto, California, United States, 94304