Description:
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.
Title
- Brief Title: Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma
- 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
Clinical Trial IDs
- ORG STUDY ID:
172058
- NCT ID:
NCT03795610
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
Interventions
Drug | Synonyms | Arms |
---|
IPI-549 | | Arm A: IPI-549 40 mg PO qdaily |
Purpose
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.
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 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.
Trial Arms
Name | Type | Description | Interventions |
---|
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 21 days | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | PI3K-y changes |
Time Frame: | 2 years |
Safety Issue: | |
Description: | To detect IPI-549-induced changes in PI3Kγ-regulated signatures of immune suppression. |
Secondary Outcome Measures
Measure: | Changes of Myeloid composition |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Compare pre- vs. post-treatment tumor tissue |
Measure: | changes in T cell composition |
Time Frame: | 2 years |
Safety Issue: | |
Description: | T cell receptor (TCR) sequencing at baseline, surgery, end of treatment or at time of disease progression. |
Measure: | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
Time Frame: | 2 years |
Safety Issue: | |
Description: | To determine safety and tolerability of IPI-549 and change in tumor size in patients with locally advanced HNSCC |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Ezra Cohen |
Trial Keywords
- HPV positive
- HPV negative
- HPV-
- HPV+
- PI3K-γ
- microenvironment
- immunotherapy
- tumor
- resection
- PI3K
- cancer
- carcinoma
- malignancy
- head
- neck
- throat
- esophageal
- nasopharyngeal
- nasopharynx
Last Updated
June 9, 2021