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Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma

NCT03795610

Description:

The purpose of this study is to investigate how effective the study drug IPI-549 is against types of cancers. IPI-549 is considered experimental because it is not approved by the US Food and Drug Administration (FDA) for the treatment of cancer. Patients will be treated with 3 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma
  • Official Title: Phase 2 Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: 172058
  • NCT ID: NCT03795610

Conditions

  • Head and Neck Squamous Cell Carcinoma
  • Head and Neck Cancer
  • Head and Neck Carcinoma
  • Head and Neck Cancer Stage IV
  • Head and Neck Cancer Stage III
  • HPV-Related Carcinoma
  • HPV-Related Malignancy
  • HPV-Related Squamous Cell Carcinoma

Interventions

DrugSynonymsArms
IPI-549Arm A: IPI-549 40 mg PO qdaily

Purpose

The purpose of this study is to investigate how effective the study drug IPI-549 is against types of cancers. IPI-549 is considered experimental because it is not approved by the US Food and Drug Administration (FDA) for the treatment of cancer. Patients will be treated with 3 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.

Detailed Description

      This is a phase 2 window of opportunity trial in patients with locally advanced head and neck
      cancer. A key objective is to provide the first proof that macrophage phenotype switching can
      be accomplished in humans and lay the groundwork for future trials of this novel approach to
      immune therapy. Patients who are candidates for surgical resection will be enrolled and
      treated with 3 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research
      purposes through core biopsies will be obtained prior to initiation of IPI-549 and at
      surgery.

      The study team hypothesizes that mRNA signatures of immune response will be increased in
      IPI-549-treated patients. For the efficacy endpoints, RECISTv1.1 will be used.
    

Trial Arms

NameTypeDescriptionInterventions
Arm A: IPI-549 40 mg PO qdailyExperimentalPatients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 21 days
  • IPI-549

Eligibility Criteria

        Inclusion Criteria:

          -  Have locally advanced that is amenable to surgical resection

          -  Must be able to swallow tablets

          -  Must be able to undergo a core tumor biopsy.

          -  Must have adequate organ function.

        Exclusion Criteria:

          -  Diagnosis of cutaneous squamous cell carcinoma (SCC) or Epstein-Barr virus (EBV)
             related nasopharynx cancer.

          -  Planned major surgery within 4 weeks prior to initiation of study drug

          -  Patients treated with chemotherapy, biologic therapy, or other investigational agent
             within < 28 days of starting study drug

          -  History of infection with human immunodeficiency virus (HIV), hepatitis B, or
             hepatitis C virus (HCV)

          -  On going treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic
             steroids

          -  Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g.
             gastric bypass surgery, gastrectomy)

          -  Female subjects who are pregnant or breastfeeding

          -  Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of
             the cervix, or prostate intraepithelial neoplasia
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:PI3K-y changes
Time Frame:2 years
Safety Issue:
Description:To detect IPI-549-induced changes in PI3Kγ-regulated signatures of immune suppression.

Secondary Outcome Measures

Measure:Changes of Myeloid composition
Time Frame:2 years
Safety Issue:
Description:Compare pre- vs. post-treatment tumor tissue
Measure:changes in T cell composition
Time Frame:2 years
Safety Issue:
Description:T cell receptor (TCR) sequencing at baseline, surgery, end of treatment or at time of disease progression.
Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame:2 years
Safety Issue:
Description:To determine safety and tolerability of IPI-549 and change in tumor size in patients with locally advanced HNSCC

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Ezra Cohen

Trial Keywords

  • HPV positive
  • HPV negative
  • HPV-
  • HPV+
  • PI3K-γ
  • microenvironment
  • immunotherapy
  • tumor
  • resection
  • PI3K
  • cancer
  • carcinoma
  • malignancy
  • head
  • neck
  • throat
  • esophageal
  • nasopharyngeal
  • nasopharynx

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