NCT04188951

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

HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer High Risk Pathologic Features Following Surgical Salvage and Are Not Eligible for Post-operative Radiation Therapy

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Approximately 30-40% of patients treated with a curative intent for locally advanced squamous cell carcinoma of the head and neck cancer will experience an isolated loco-regional recurrence or a second primary tumor in the previously radiated tissues1-5. Patients with recurrent head and neck cancer frequently recur locally and are still amenable for curative interventions. The current recommendations for treatment of these recurrent and second primary tumors includes surgical resection whenever possible as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy. Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Many trials underway at the present time explore the use of immunotherapy in earlier stages of head and neck cancer than the ones already studied. However, patients undergoing salvage therapy are understudied and no major cooperative group or industry trial is addressing this group of patients.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]	Patients will receive 17 cycles of pembrolizumab via IV infusion of 200 mg over a period of 30 minutes, every 3 weeks starting no later than 90 days from the date of salvage head and neck therapy.

Timeline

• Start date: 2019-10-04
• Primary completion: 2023-06-15
• Completion: 2024-05-08
• First posted: 2019-12-06
• Last updated: 2024-12-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study