Safety and Efficacy of MEDI0457 and Durvalumab in Participants With Human Papilloma Virus (HPV) Associated Recurrent/Metastatic Head and Neck Cancer

Completed · Phase 1/Phase 2

Conditions studied: Head and Neck Cancer, Human Papilloma Virus

In brief

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 Deoxyribonucleic Acid (DNA) vaccine in combination with durvalumab (also known as MEDI4736) which is a human monoclonal antibody directed against Programmed Death Ligand 1 (PD-L1), which blocks the interaction of PD-L1 with PD-1 and Cluster of differentiation 80 (CD80). An initial three to 12 participants (Safety Analysis Run-in participants) will be enrolled and assessed for safety before additional participants are enrolled. The initial safety analysis run-in participants along with an approximate total of 50 participants with human papilloma virus associated recurrent or metastatic head and neck squamous cell cancer (HNSCC) will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457 in combination with durvalumab.

Key facts

Study ID

NCT03162224

Run by

MedImmune LLC

People needed

35

Starts

2017-06-26

Expected to finish

2021-03-19

Last updated by the study team

2022-08-25

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants 18 years and older
• 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.
• Recurrent or metastatic disease that has been treated with at least one platinum-containing regimen and lacking a curative treatment option.
• Participants who are platinum ineligible may be enrolled if they have received and failed an approved treatment and lack a treatment option with curative potential.

You may not qualify if…

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

Where it is running

• Research Site — San Francisco, California, United States
• Research Site — Orlando, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Morristown, New Jersey, United States
• Research Site — The Bronx, New York, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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