Back to resultsHFHS-1801-A Pilot Study of Immunotherapy as Consolidation Therapy for Patients With Recurrent Head and Neck Cancer
Primary Purpose
Head and Neck Neoplasms
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring Recurrent Head and Neck Cancer, Recurrent Head and Neck Neoplasms
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
- Patients with synchronous cancers "not included in the inclusion criteria"
Sites / Locations
- Henry Ford Health SystemRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Rate of completion of all planned therapy. All drug related toxicities will be graded by CTCAE v5.0.
Study endpoint
Toxicity rates measured by laboratory assessments and all adverse events and serious adverse events will be assessed by CTCAE v5.0.
Study endpoint
Full Information
NCT ID
NCT04188951
First Posted
October 31, 2019
Last Updated
December 19, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT04188951
Brief Title
HFHS-1801-A Pilot Study of Immunotherapy as Consolidation Therapy for Patients With Recurrent Head and Neck Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms
Keywords
Recurrent Head and Neck Cancer, Recurrent Head and Neck Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
Intervention Description
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 Measure Information:
Title
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).
Description
Primary objective
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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.
Description
Study endpoint
Time Frame
1 year
Title
Rate of completion of all planned therapy. All drug related toxicities will be graded by CTCAE v5.0.
Description
Study endpoint
Time Frame
through study completion, an average of 1 year
Title
Toxicity rates measured by laboratory assessments and all adverse events and serious adverse events will be assessed by CTCAE v5.0.
Description
Study endpoint
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Patients with synchronous cancers "not included in the inclusion criteria"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Gaggin, BSN
Phone
313-916-3731
Email
JGAGGIN1@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Picotte, BS
Phone
313-916-3181
Email
fpicott1@hfhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haythem Ali, MD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Gaggin, BSN
Phone
313-916-3731
Email
JGAGGIN1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Haythem Ali, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
HFHS-1801-A Pilot Study of Immunotherapy as Consolidation Therapy for Patients With Recurrent Head and Neck Cancer
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