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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT04188951
Eligibility Criteria:
Inclusion Criteria:
* Patients must be 18 years or older, of either gender, with the ability to consent to participation in the study.
* Patients must have a history of squamous cell carcinoma of the head and neck involving any sub-site in the head and neck area except nasopharynx, paranasal sinuses, and salivary gland tumors.
* All patients must have recurred following definitive therapy with any combination of surgery, radiation, and/or chemotherapy.
* All patients must have undergone salvage surgery in an attempt to excise all recurrent disease.
* Salvage radiation therapy must not be an option available to the patient.
* Patients must have high risk features such extra nodal invasion, positive margins, perineural invasion or vascular embolism.
Exclusion Criteria:
* Patients with macroscopic residual disease
* Patient is eligible for radiation therapy.
* Performance status more than 2.
* Contraindications for immunotherapy, autoimmune disease, allergy to medication, steroid use at baseline.
* Patients with other previous cancers excluding CIN, DCIS, non-melanoma skin cancers
* Patients previously treated with immunotherapy \<12months prior
* Patients with synchronous cancers "not included in the inclusion criteria"
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04188951
Study Brief:
Protocol Section:
NCT04188951