HFHS-1801-A Pilot Study of Immunotherapy as Consolidation Therapy for Patients With Recurrent Head and Neck Cancer

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Ford Health System
• Treatments: Pembrolizumab

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"