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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188951
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : December 20, 2022
Sponsor:
Information provided by (Responsible Party):
Haythem Ali, M.D., Henry Ford Health System

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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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). [ Time Frame: 1 year ]
    Primary objective


Secondary Outcome Measures :
  1. 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. [ Time Frame: 1 year ]
    Study endpoint

  2. Rate of completion of all planned therapy. All drug related toxicities will be graded by CTCAE v5.0. [ Time Frame: through study completion, an average of 1 year ]
    Study endpoint

  3. Toxicity rates measured by laboratory assessments and all adverse events and serious adverse events will be assessed by CTCAE v5.0. [ Time Frame: through study completion, an average of 1 year ]
    Study endpoint



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Patients with synchronous cancers "not included in the inclusion criteria"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188951


Contacts
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Contact: John Gaggin, BSN 313-916-3731 JGAGGIN1@hfhs.org
Contact: Francesca Picotte, BS 313-916-3181 fpicott1@hfhs.org

Locations
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United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: John Gaggin, BSN    313-916-3731    JGAGGIN1@hfhs.org   
Principal Investigator: Haythem Ali, MD         
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Haythem Ali, MD Henry Ford Health System
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Responsible Party: Haythem Ali, M.D., Principle Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT04188951    
Other Study ID Numbers: HFHS-1801
First Posted: December 6, 2019    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data will become available after the study has completed enrollment and patient treatment. The data will be available indefinitely unless specified.
Access Criteria: Access will be limited to collaborators within and beyond Henry Ford Health System.

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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
Keywords provided by Haythem Ali, M.D., Henry Ford Health System:
Recurrent Head and Neck Cancer
Recurrent Head and Neck Neoplasms
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents