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

Phase 2

Completed

• Conditions: Head and Neck Cancer; Head and Neck Cancer Stage IV; HPV-Related Squamous Cell Carcinoma; HPV-Related Malignancy; Head and Neck Carcinoma; Head and Neck Cancer Stage III; HPV-Related Carcinoma; Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: IPI-549

• Registration Number: NCT03795610
• Lead Sponsor: Assuntina G. Sacco, MD

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 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.

Study Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-08
• Study Start: 2020-03-06
• Primary Completion: 2022-12-22
• Study Completion: 2023-08-24
• Results First Submitted: 2025-06-09
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Results First Posted: 2025-07-25
• Last Update Posted: 2025-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A: IPI-549 40 mg PO qdaily	IPI-549	Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days

Primary Outcome Measures

Name	Time	Method
Participants Experiencing Adverse Events	7 weeks	To determine safety and tolerability of IPI-549 in patients with locally advanced HNSCC.

Trial Locations

Locations (1)

UC San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States