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:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT03129061
Eligibility Criteria:
Inclusion Criteria:
* Unresectable or metastatic SCCHN.
* Localized SCCHN.
* \>18 years old.
* Willing and able to sign consent form.
* Have standard of care biopsy or resection planned or tumors amenable to serial biopsies.
* For patients with reproductive potential must undergo counseling to understand unknown risks to resultant progeny.
Exclusion Criteria:
* Diagnosis of immunodeficiency or active autoimmune condition.
* Active tuberculosis
* Prior exposure to PD-1 or PD-LI treatment
* Prior systemic chemotherapy within 2 weeks of planed anti-PD1 treatment.
* Received a live vaccine within 30 days of planned PD-1 start date.
* Pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03129061
Study Brief:
Protocol Section:
NCT03129061