for people ages 18 years and up (full criteria)
at La Jolla, California
study started
completion around
Principal Investigator
by Ezra Cohen, MD
Headshot of Ezra Cohen
Ezra Cohen



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.

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


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.


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, HPV positive, HPV negative, HPV-, HPV+, PI3K-γ, microenvironment, immunotherapy, tumor, resection, PI3K, cancer, carcinoma, malignancy, head, neck, throat, esophageal, nasopharyngeal, nasopharynx, Squamous Cell Carcinoma, Neoplasms, Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, IPI-549, IPI-549 40 mg PO qdaily


You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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


  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Ezra Cohen, MD
    Associate Physician, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 247 research publications


accepting new patients
Start Date
Completion Date
Ezra Cohen
Phase 2 research study
Study Type
Expecting 15 study participants
Last Updated