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

  • participants needed
  • sponsor
    Henry Ford Health System
Updated on 2 February 2023
squamous cell carcinoma
definitive treatment
head and neck cancer
squamous cell carcinoma of head and neck
neck cancer
salvage surgery
head and neck carcinoma
recurrent head and neck carcinoma


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


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.

Condition Head and Neck Neoplasms
Treatment Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
Clinical Study IdentifierNCT04188951
SponsorHenry Ford Health System
Last Modified on2 February 2023

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