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

Purpose

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.

Condition

  • Head and Neck Squamous Cell Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Kansas
Westwood, Kansas 66205
Contact:
Rahul Chanolian
913-588-6029
rchanolian@kumc.edu

More Details

Status
Recruiting
Sponsor
Tempus AI

Study Contact

Phoenix HNSCC
(833) 514-4187
phoenix@tempus.com