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

Tempus AI

Status: Enrolling

Conditions: Head and Neck Squamous Cell Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT06163534

Pro00074943 (Other Identifier)

TP-CA-006

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

500 participants in 1 patient group

Metastatic or unresectable recurrent HNSCC

Description:

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.