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

G
Greg Durm, MD

Primary Investigator

Overview

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.

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.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    human papilloma virus,head and neck squamous cancer,head and neck squamous cancer
  • Age: Between 18 Years - 100 Years
  • 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).


Additional Information:
Participants will not be paid for their participation.

Updated on 20 Nov 2022. Study ID: 1710750968 (D8860C00005)

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

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