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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT02124850
Eligibility Criteria:
Inclusion Criteria:
* Previously untreated stage II, III, or IVA histologically or cytologically confirmed squamous cell carcinoma of the head and neck
* Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx
* Macroscopic complete resection of the primary tumor must be planned
* Age ≥ 18 years
* ECOG performance status 0-1
* Adequate hematologic, renal and hepatic function
* Have signed written informed consent
Exclusion Criteria:
* Subjects who fail to meet inclusion criteria
* Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown primary tumors
* Prior severe infusion reaction to a monoclonal antibody
* Pregnancy or breastfeeding
* Evidence of distant metastasis
* Any other malignancy active within 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix, DCIS or LCIS of the breast
* Prior history of head and neck cancer
* Prior therapy with motolimod, nivolumab, or other agents targeting PD-1/PD-L1
* Prior therapy targeting the EGFR pathway
* Acute hepatitis, known HIV, or active uncontrolled infection
* Patients with active autoimmune disease
* History of uncontrolled cardiac disease within prior 6 months
* Uncontrolled peptic or gastric ulcer disease, or gastrointestinal bleeding within prior 6 months
* Active alcohol abuse or other illness or circumstance that carries a likelihood of inability to comply with study treatment and follow-up or otherwise compromise the study's objectives
* Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of study treatment
* Live vaccine within 30 days of planned start of study therapy
* History of pneumonitis or interstitial lung disease
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02124850
Study Brief:
Protocol Section:
NCT02124850