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 Human Papilloma Virus Associated Head and Neck Squamous Cancer
Investigation of an Investigational Vaccine and Treatment for HPV-related Head and Neck Cancer
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: human papilloma virus
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
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
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
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).
This study investigates the use of an investigational vaccine combined with an immune therapy to treat patients with head and neck cancer linked to the human papilloma virus (HPV). Head and neck cancer can occur in areas such as the throat, mouth, and nose, and when linked to HPV, it is often more challenging to treat. This study aims to understand how effective and safe the combination treatment is for patients whose cancer has returned or spread.
Participants in the study will receive either the investigational vaccine combined with an immune therapy or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will involve monitoring the participants' health and response to the treatment to gather data on its safety and effectiveness.
- Who can participate: Adults with head and neck squamous cell carcinoma associated with HPV can participate if their cancer has returned or spread after treatment. Participants must have been treated with a platinum-containing regimen and lack curative treatment options. HPV confirmation by p16 IHC or HPV-16/18 nucleic acid testing is required.
- Study details: Participants will receive either the investigational vaccine and immune therapy or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
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