IRB Study Number 25-781
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Taussig Cancer Institute
Description
Primary Objectives
● To create a robust multi-omic dataset composed of rich molecular and clinical data for metastatic or unresectable, recurrent HNSCC patients who receive standard of care CPI therapy for the purposes of understanding the relationship between biomarkers and real-world outcomes of standard of care therapies.
Exploratory Objectives
● Assess biomarker landscape in diagnostic biopsy specimens and determine association with response rate, risk of progression and survival outcomes in participants undergoing SoC immunotherapy or immunotherapy containing regimens.
● Assess biomarker landscape in the progression specimen and draw paired comparisons with baseline tumor tissue samples.
● Assess T-cell receptor landscape in tumor tissue and/or peripheral blood samples and draw associations with clinical outcomes.
● Assess ctDNA detection technologies as a response biomarker in metastatic or unresectable, recurrent HNSCC and/or to detect mutations and/or copy-number events.
● Investigate other biomarkers in tumor and periphery at baseline, on treatment, and/or at progression wherever feasible to identify markers related to disease, mechanism of action of the drug/or their associations with response and clinical endpoints.
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 fresh or archived block tumor 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)
