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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT04129320
Eligibility Criteria:
Inclusion Criteria:
* Histologically proven, recurrent or metastatic SCCHN not curable by local therapy
* No prior systemic therapy for SCCHN in the recurrent or metastatic setting (with the exception of systemic therapy completed \> 6 months prior of given as part of multimodal treatment for locally advanced disease)
* Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx
* At least one radiographically measurable lesion
* HPV test results available (positive and negative eligible)
* ECOG Performance status of 0 or 1
* Adequate end organ function
* Positive PD-L1 expression level (CPS ≥ 1%)
Exclusion Criteria:
* Disease suitable for local therapy administered with curative intent
* Progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced SCCHN
* Radiation or other non-systemic therapy within 2 weeks of first dose of study drug
* Diagnosis of immunodeficiency, or use of immunosuppresive therapy within 14 days of first dose of study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04129320
Study Brief:
Protocol Section:
NCT04129320