MEDI0457 & Durvalumab w/ HPV Recurrent/Metastatic Cancer

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

  • Clinical Trial Information

    Trial Contact: Marchese, Sean N; Durand, Jennifer

    Trial Phone: 321.841.4348 ; 321.843.2026

  • IRB No: 18.060.05

    Protocol Abbrev: D8860C00005

    Principal Investigator: Tirrell Tremayne Johnson, MD

    Phase: Drug: Phase I

    Age Group: Adult

    Treatment: MEDI0457, Durvalumab, CELLECTRA®5P device (CELLECTRA 2000)

    Therapies Involved: Medication ID: NCT03162224

  • Objective

    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.

  • Key Eligibility

    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.