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

Assuntina G. Sacco, MD

Status and phase

Completed

Phase 2

Conditions

HPV-Related Carcinoma

Head and Neck Carcinoma

HPV-Related Squamous Cell Carcinoma

Head and Neck Cancer Stage III

HPV-Related Malignancy

Head and Neck Cancer

Head and Neck Cancer Stage IV

Head and Neck Squamous Cell Carcinoma

Treatments

Drug: IPI-549

Study type

Interventional

Funder types

Other

Identifiers

NCT03795610

172058

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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