NCT03795610

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Assuntina G. Sacco, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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.

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

Type	Name	Description
DRUG	IPI-549	40mg by mouth (PO) every day (QD) for at least 14 days

Timeline

• Start date: 2020-03-06
• Primary completion: 2022-12-22
• Completion: 2023-08-24
• First posted: 2019-01-08
• Last updated: 2025-07-25
• Results posted: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study