Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT06163534
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06163534
Study Brief:
Protocol Section:
NCT06163534