Summary

for people ages 18-99 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Alain Algazi

Description

Summary

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. An initial three to 12 patients (Safety Analysis Run-in patients) will be enrolled and assessed for safety before additional patients are enrolled. The initial safety analysis run-in patients along with an approximate total of 50 patients with human papilloma virus associated recurrent or metastatic head and neck squamous cell cancer will be enrolled in this study and evaluated also for anti-tumor efficacy to MEDI0457 in combination with durvalumab.

Official Title

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

Keywords

Head and Neck Cancer Human Papilloma Virus Head and Neck Squamous Cell Carcinoma Oropharyngeal Cancer HPV Cancer Immunotherapy Check point inhibitors PD-L1 inhibitor Recurrent or Metastatic Cancer Durvalumab MEDI0457 Antineoplastic agents Neoplasms Head and Neck Neoplasms Papilloma Antibodies, Monoclonal CELLECTRA®5P device (CELLECTRA 2000) HPV associated recurrent/metastatic HNSCC

Eligibility

You can join if…

Open to people ages 18-99

  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.

You CAN'T join if...

  1. Any concurrent chemotherapy, immune-mediated therapy or biologic or hormonal therapy for cancer treatment Active or prior documented autoimmune disease with some exceptions.
  2. 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.
  3. 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).

Locations

  • Research Site
    San Francisco California 94115 United States
  • Research Site
    Minneapolis Minnesota 55455 United States

Lead Scientist

  • Alain Algazi
    Associate Professor, Medicine. Authored (or co-authored) 54 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MedImmune LLC
ID
NCT03162224
Phase
Phase 1/2
Study Type
Interventional
Last Updated