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

Launched by TEMPUS AI · Nov 30, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on studying patients with Head and Neck Squamous Cell Carcinoma (HNSCC), a type of cancer affecting the head and neck area. Researchers will collect and analyze tissue and blood samples from participants during their standard treatment to better understand the molecular markers that may influence the disease and its response to therapy. This study aims to improve personalized treatment options for patients battling this cancer.

To be eligible for this trial, participants must be at least 18 years old and willing to provide informed consent. They should have a confirmed diagnosis of metastatic or recurrent HNSCC that cannot be treated with local therapies and be planning to start a specific type of treatment called anti-PD1 or PD-L1 therapy. Participants will need to provide a sample of their tumor tissue for testing. While the study is open to all genders, those with certain types of tumors or other active cancers may not qualify. If chosen to participate, individuals can expect to undergo regular assessments and provide additional blood samples during their treatment, contributing to important research that could benefit future patients.

Gender

ALL

Eligibility criteria

• 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)