Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03795610|
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
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 3 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|
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 3 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2023|
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 21 days
40mg by mouth (PO) every day (QD) for at least 21 days
- PI3K-y changes [ Time Frame: 2 years ]To detect IPI-549-induced changes in PI3Kγ-regulated signatures of immune suppression.
- Changes of Myeloid composition [ Time Frame: 2 years ]Compare pre- vs. post-treatment tumor tissue
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795610
|Contact: Gerald Hendersonemail@example.com|
|Contact: Elaine Engfirstname.lastname@example.org|
|United States, California|
|UC San Diego Moores Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Ezra Cohen, MD||University of California, San Diego|