Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma
- Conditions
- Head and Neck CancerHead and Neck Cancer Stage IVHPV-Related Squamous Cell CarcinomaHPV-Related MalignancyHead and Neck CarcinomaHead and Neck Cancer Stage IIIHPV-Related CarcinomaHead and Neck Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT03795610
- Lead Sponsor
- Ezra Cohen
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A: IPI-549 40 mg PO qdaily IPI-549 Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days
- Primary Outcome Measures
Name Time Method PI3K-y changes 2 years To detect IPI-549-induced changes in PI3Kγ-regulated signatures of immune suppression.
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 2 years To determine safety and tolerability of IPI-549 and change in tumor size in patients with locally advanced HNSCC
changes in T cell composition 2 years T cell receptor (TCR) sequencing at baseline, surgery, end of treatment or at time of disease progression.
Changes of Myeloid composition 2 years Compare pre- vs. post-treatment tumor tissue
Trial Locations
- Locations (1)
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States