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

July 8, 2025 updated by: Assuntina G. Sacco, MD

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

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 2 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 2 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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 14 days
Drug: IPI-549
40mg by mouth (PO) every day (QD) for at least 14 days
Other Names:
  • Eganelisib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants Experiencing Adverse Events
Time Frame: 7 weeks
To determine safety and tolerability of IPI-549 in patients with locally advanced HNSCC.
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Myeloid composition
Time Frame: 2 years
Compare pre- vs. post-treatment tumor tissue
2 years
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.
2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuntina G. Sacco, MD

Collaborators

The V Foundation for Cancer Research

Investigators

  • Principal Investigator: Ezra Cohen, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2020

Primary Completion (Actual)

December 22, 2022

Study Completion (Actual)

August 24, 2023

Study Registration Dates

First Submitted

December 21, 2018

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 8, 2019

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 172058

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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