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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT02641093
Eligibility Criteria:
Inclusion Criteria:
* Patients eligible for resection with one or more of the following
1. Any T stage with ≥ N2 disease;
2. T4 disease, any N stage;
3. T3 Oral Cavity, any N stage; or
4. Clinical evidence of extra-capsular extension on scans.
* Must be willing to undergo definitive resection with neck dissection.
* Performance status 0 or 1 on Eastern Cooperative Oncology Group Performance Scale.
* Adequate labs
* Appropriate staging imaging.
Exclusion Criteria:
* Diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment.
* Nasopharyngeal or sinonasal carcinoma
* Confirmed metastatic disease
* Human Papillomavirus (HPV)+ disease of the oropharynx
* Known history of active tuberculosis (TB), autoimmune disease, pneumonitis, infection, HIV, Hepatitis B, or Hepatitis C
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02641093
Study Brief:
Protocol Section:
NCT02641093