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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

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ClinicalTrials.gov Identifier: NCT03795610
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
The V Foundation for Cancer Research
Information provided by (Responsible Party):
Ezra Cohen, University of California, San Diego

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
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 Drug: IPI-549 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: IPI-549 40 mg PO qdaily
Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 21 days
Drug: IPI-549
40mg by mouth (PO) every day (QD) for at least 21 days




Primary Outcome Measures :
  1. PI3K-y changes [ Time Frame: 2 years ]
    To detect IPI-549-induced changes in PI3Kγ-regulated signatures of immune suppression.


Secondary Outcome Measures :
  1. Changes of Myeloid composition [ Time Frame: 2 years ]
    Compare pre- vs. post-treatment tumor tissue

  2. changes in T cell composition [ Time Frame: 2 years ]
    T cell receptor (TCR) sequencing at baseline, surgery, end of treatment or at time of disease progression.

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 2 years ]
    To determine safety and tolerability of IPI-549 and change in tumor size in patients with locally advanced HNSCC



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03795610


Contacts
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Contact: Gerald Henderson 858-822-5223 gehenderson@ucsd.edu
Contact: Elaine Eng e1eng@ucsd.edu

Locations
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United States, California
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
Ezra Cohen
The V Foundation for Cancer Research
Investigators
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Principal Investigator: Ezra Cohen, MD University of California, San Diego

Publications:

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Responsible Party: Ezra Cohen, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03795610     History of Changes
Other Study ID Numbers: 172058
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ezra Cohen, University of California, San Diego:
HPV positive
HPV negative
HPV-
HPV+
PI3K-γ
microenvironment
immunotherapy
tumor
resection
PI3K
cancer
carcinoma
malignancy
head
neck
throat
esophageal
nasopharyngeal
nasopharynx
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site