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

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Henry Ford Health

Status and phase

Enrolling
Early Phase 1

Conditions

Head and Neck Neoplasms

Treatments

Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

Study type

Interventional

Funder types

Other

Identifiers

NCT04188951
HFHS-1801

Details and patient eligibility

About

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

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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"

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
Other group
Treatment:
Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

Trial contacts and locations

0

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Central trial contact

Francesca Picotte, BS; John Gaggin, BSN

Data sourced from clinicaltrials.gov

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