Clinical Trials /

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

NCT04188951

Description:

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

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

URL:

https://clinicaltrials.gov/show/NCT04188951

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: HFHS-1801
  • NCT ID: NCT04188951

Conditions

  • Head and Neck Neoplasms

Interventions

DrugSynonymsArms
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]Other
  • Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]

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"
Maximum Eligible Age:85 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:Primary objective

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:Study endpoint
Measure: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
Safety Issue:
Description:Study endpoint
Measure: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
Safety Issue:
Description:Study endpoint

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Henry Ford Health System

Trial Keywords

  • Recurrent Head and Neck Cancer
  • Recurrent Head and Neck Neoplasms

Last Updated

December 6, 2019