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

NCT ID: NCT04188951

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2024-05-08

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

Group Type: OTHER

Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Haythem Ali, M.D.

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haythem Ali, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Henry Ford Health System

Detroit, Michigan, United States

Countries

United States

Other Identifiers

HFHS-1801

Identifier Type: -

Identifier Source: org_study_id