Summary

for people ages 18 years and up (full criteria)
at La Jolla, California
study started
estimated completion
Ezra Cohen, MD

Description

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.

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

Details

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.

Keywords

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 Carcinoma, Squamous Cell Head and Neck Neoplasms Squamous Cell Carcinoma of Head and Neck Neoplasms IPI-549

Eligibility

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

Location

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

Lead Scientist

  • Ezra Cohen, MD
    Professor, Medicine. Authored (or co-authored) 175 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Ezra Cohen
ID
NCT03795610
Phase
Phase 2
Study Type
Interventional
Last Updated