Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/10/2019 |
| Start Date: | June 2019 |
| End Date: | June 2023 |
| Contact: | Gerald Henderson |
| Email: | gehenderson@ucsd.edu |
| Phone: | 858-822-5223 |
Phase 2 Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma
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.
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.
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.
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.
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
We found this trial at
1
site
3855 Health Sciences Dr,
La Jolla, California 92093
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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