Safety and Efficacy of MEDI0457 and Durvalumab in Patients With HPV Associated Recurrent/Metastatic Head and Neck Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Oncology
Healthy:No
Age Range:18 - 99
Updated:4/3/2019
Start Date:June 26, 2017
End Date:August 10, 2020
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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A Phase 1b/2a, Multi-Center Open-Label Study to Evaluate the Safety and Efficacy of Combination Treatment With MEDI0457 (INO-3112) and Durvalumab (MEDI4736) in Patients With Recurrent/Metastatic HPV Associated Head and Neck Squamous Cancer

This is a Phase 1b/2a, open-label, multi-center study to evaluate the safety and
tolerability, anti-tumor activity, and immunogenicity of MEDI0457 (also known as INO 3112) a
HPV DNA vaccine in combination with durvalumab (also known as MEDI4736) which is a human
monoclonal antibody directed against PD-L1, which blocks the interaction of PD-L1 with PD-1
and CD80.

An initial three to 12 patients (Safety Analysis Run-in patients) will be enrolled and
assessed for safety before additional patients are enrolled.

The initial safety analysis run-in patients along with an approximate total of 50 patients
with human papilloma virus associated recurrent or metastatic head and neck squamous cell
cancer will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457
in combination with durvalumab.


Inclusion Criteria:

1. Male and female subjects 18 years and older

2. Histologically or cytologically confirmed diagnosis of HNSCC associated with HPV by a
p16 immunohistochemistry (IHC) assay or HPV-16 or HPV-18 positive by nucleic acid
testing.

3. Recurrent or metastatic disease that has been treated with at least one
platinum-containing regimen and lacking a curative treatment option.

4. Patients who are platinum ineligible may be enrolled if they have received and failed
an approved treatment and lack a treatment option with curative potential.

Exclusion criteria:

1. Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy
for cancer treatment Active or prior documented autoimmune disease with some
exceptions.

2. Current or prior use of immunosuppressive medication within 14 days prior to first
study dose, with the exception of intranasal and inhaled corticosteroids or systemic
corticosteroids at doses not to exceed 10 mg/day of prednisone or equivalent. Steroids
as premedication for hypersensitivity reactions due to radiographic contrast agents
are allowed.

3. No prior exposure to immune-mediated therapy defined as prior exposure to T-cell and
natural killer cell directed therapy (e.g., anti-PD-1, anti-PD-L1, anti-CD137, and
anti-CTLA4, etc).
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