Clinical Trial TitleA 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.
Clinical Trial Protocol Description:
The purpose of this research study is to measure how well and how safe MEDI0457 vaccine, in combination with durvalumab, is in treating patients with recurrent/metastatic human papilloma virus associated head and neck squamous cancer. This will be done by treatment with MEDI0457 and durvalumab.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have 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.
- Have recurrent or metastatic disease that has been treated with at least one platinum-containing regimen and lacking a curative treatment option.
- Are platinum ineligible may be enrolled if they have received and failed an approved treatment and lack a treatment option with curative potential.
You will be excluded from the study if any of the following criteria apply to you:
- Are undergoing concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment. Active or prior documented autoimmune disease with some exceptions.
- Are currently on or have 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.
- HAve had 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).
This is a partial list of inclusion and exclusion criteria.