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

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: John Gaggin, BSN; Phone Number: 313-916-3731; Email: JGAGGIN1@hfhs.org
• Study Contact Backup: Name: Francesca Picotte, BS; Phone Number: 313-916-3181; Email: fpicott1@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health System
      • Principal Investigator: Haythem Ali, MD
      • Contact: John Gaggin, BSN; Phone Number: 313-916-3731; Email: JGAGGIN1@hfhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of recurrence at 1 year, will be measured by RECIST 1.1 as the primary measure for assessment of tumor, date of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., discontinuation of study treatment).	Primary objective	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the feasibility of immunotherapy for head and neck cancer following salvage surgery to produce preliminary data for 15 patients regarding efficacy. All side effects and symptoms will be assessed by CTCAE v5.0.	Study endpoint	1 year
Rate of completion of all planned therapy. All drug related toxicities will be graded by CTCAE v5.0.	Study endpoint	through study completion, an average of 1 year
Toxicity rates measured by laboratory assessments and all adverse events and serious adverse events will be assessed by CTCAE v5.0.	Study endpoint	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Haythem Ali, MD, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Recurrent Head and Neck Cancer; Recurrent Head and Neck Neoplasms
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Pembrolizumab
• Other Study ID Numbers: HFHS-1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: This study is to obtain pilot data. The data may be shared with other researchers. Participants will sign a research HIPAA authorization to release their data. All participants will be assigned a study specific ID number.
• IPD Sharing Time Frame: Data will become available after the study has completed enrollment and patient treatment. The data will be available indefinitely unless specified.
• IPD Sharing Access Criteria: Access will be limited to collaborators within and beyond Henry Ford Health System.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No