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

NCT03795610 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 172058
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

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

Keywords

HPV positive; HPV negative; HPV-; HPV+; PI3K-γ; microenvironment; immunotherapy; tumor; resection; PI3K; cancer; carcinoma; malignancy; head; neck; throat; esophageal; nasopharyngeal; nasopharynx

Outcome Measures

Primary Outcomes (1)

• Participants Experiencing Adverse Events

  To determine safety and tolerability of IPI-549 in patients with locally advanced HNSCC.

  7 weeks

Study Arms (1)

Arm A: IPI-549 40 mg PO qdaily

EXPERIMENTAL

Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days

Drug: IPI-549

Interventions

IPI-549 DRUG

40mg by mouth (PO) every day (QD) for at least 14 days

Also known as: Eganelisib

Arm A: IPI-549 40 mg PO qdaily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Assuntina G. Sacco, MD: lead
• The V Foundation for Cancer Research: collaborator

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (6)

• Kaneda MM, Cappello P, Nguyen AV, Ralainirina N, Hardamon CR, Foubert P, Schmid MC, Sun P, Mose E, Bouvet M, Lowy AM, Valasek MA, Sasik R, Novelli F, Hirsch E, Varner JA. Macrophage PI3Kgamma Drives Pancreatic Ductal Adenocarcinoma Progression. Cancer Discov. 2016 Aug;6(8):870-85. doi: 10.1158/2159-8290.CD-15-1346. Epub 2016 May 13.

  PMID: 27179037 BACKGROUND

• Kaneda MM, Messer KS, Ralainirina N, Li H, Leem CJ, Gorjestani S, Woo G, Nguyen AV, Figueiredo CC, Foubert P, Schmid MC, Pink M, Winkler DG, Rausch M, Palombella VJ, Kutok J, McGovern K, Frazer KA, Wu X, Karin M, Sasik R, Cohen EE, Varner JA. PI3Kgamma is a molecular switch that controls immune suppression. Nature. 2016 Nov 17;539(7629):437-442. doi: 10.1038/nature19834. Epub 2016 Sep 19.

  PMID: 27642729 BACKGROUND

• De Palma M, Lewis CE. Macrophage regulation of tumor responses to anticancer therapies. Cancer Cell. 2013 Mar 18;23(3):277-86. doi: 10.1016/j.ccr.2013.02.013.

  PMID: 23518347 BACKGROUND

• Gabrilovich DI, Ostrand-Rosenberg S, Bronte V. Coordinated regulation of myeloid cells by tumours. Nat Rev Immunol. 2012 Mar 22;12(4):253-68. doi: 10.1038/nri3175.

  PMID: 22437938 BACKGROUND

• Schmid MC, Avraamides CJ, Dippold HC, Franco I, Foubert P, Ellies LG, Acevedo LM, Manglicmot JR, Song X, Wrasidlo W, Blair SL, Ginsberg MH, Cheresh DA, Hirsch E, Field SJ, Varner JA. Receptor tyrosine kinases and TLR/IL1Rs unexpectedly activate myeloid cell PI3kgamma, a single convergent point promoting tumor inflammation and progression. Cancer Cell. 2011 Jun 14;19(6):715-27. doi: 10.1016/j.ccr.2011.04.016.

  PMID: 21665146 BACKGROUND

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Neoplasms; Carcinoma

Interventions

IPI-549

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms by Site

Results Point of Contact

• Title: Dr. Assuntina Sacco
• Organization: University of California, San Diego

agsacco@health.ucsd.edu

(858) 822-6100

Study Officials

• Ezra Cohen, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: January 8, 2019
• Study Start: March 6, 2020
• Primary Completion: December 22, 2022
• Study Completion: August 24, 2023
• Last Updated: July 25, 2025
• Results First Posted: July 25, 2025

Record last verified: 2025-07

Locations

US (1)