We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03795610
Recruitment Status : Recruiting
First Posted : January 8, 2019
Last Update Posted : March 10, 2023
Sponsor:
Collaborator:
The V Foundation for Cancer Research
Information provided by (Responsible Party):
Ezra Cohen, University of California, San Diego

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
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 Drug: IPI-549 Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Arm A: IPI-549 40 mg PO qdaily
Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days
 Drug: IPI-549
40mg by mouth (PO) every day (QD) for at least 14 days


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. PI3K-y changes [ Time Frame: 2 years ]
    To detect IPI-549-induced changes in PI3Kγ-regulated signatures of immune suppression.


Secondary Outcome Measures :
  1. Changes of Myeloid composition [ Time Frame: 2 years ]
    Compare pre- vs. post-treatment tumor tissue

  2. changes in T cell composition [ Time Frame: 2 years ]
    T cell receptor (TCR) sequencing at baseline, surgery, end of treatment or at time of disease progression.

  3. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 2 years ]
    To determine safety and tolerability of IPI-549 and change in tumor size in patients with locally advanced HNSCC


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795610


Contacts
Layout table for location contacts
Contact: Debanjali Ghosh, MA 858-246-0357 d1ghosh@health.ucsd.edu
Contact: Elaine Eng e1eng@ucsd.edu

Locations
Layout table for location information
United States, California
UC San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Sponsors and Collaborators
Ezra Cohen
The V Foundation for Cancer Research
Investigators
Layout table for investigator information
Principal Investigator: Ezra Cohen, MD University of California, San Diego
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Ezra Cohen, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03795610    
Other Study ID Numbers: 172058
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: March 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ezra Cohen, University of California, San Diego:
HPV positive
HPV negative
HPV-
HPV+
PI3K-γ
microenvironment
immunotherapy
tumor
resection
PI3K
 cancer
carcinoma
malignancy
head
neck
throat
esophageal
nasopharyngeal
nasopharynx
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Neoplasms
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site