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Back|NCT06163534Recruiting
Official Title

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

Sponsor
Tempus AI
Enrollment
500
Timeline
Aug 2024 → Mar 2028
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1≥18 years of age
  • 2Willing and able to provide informed consent
  • 3Histologically- or cytologically-confirmed metastatic or unresectable, recurrent HNSCC unsuitable for local therapies
  • 4Intended for first line anti-PD1 or PDL1 monotherapy or combination therapy
  • 5Must submit tumor tissue sample representative of current disease per laboratory manual

Exclusion Criteria

  • 1Non-squamous histologies (eg, nasopharynx or salivary gland)
  • 2Relapse or recurrence within 6 months of first line chemotherapy and / or chemoradiotherapy
  • 3Tumors that are PD-L1 negative (CPS \<1)
  • 4Clinical 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
  • 5Unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)

Locations

29 sites participating in this study

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

Recruiting

Nabil Saba, MD

City of Hope

Duarte, California 91010

Recruiting

Victoria Villaflor

USC/Norris Comprehensive Cancer Center

Los Angeles, California 90033

Recruiting

Jacob Thomas

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →