About this trial

This phase Ib trial tests the safety, side effects and best dose of tumor membrane vesicle (TMV) vaccine therapy alone and in combination with pembrolizumab and evaluates how well it works in treating patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Vaccines made from a person's tumor cells, such as TMV vaccines, may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving TMV vaccine therapy alone or with pembrolizumab may be safe, tolerable and/or effective in treating patients with recurrent and/or metastatic head and neck squamous cell cancer.

Eligibility criteria

Qualifiers

Must be at least ≥ 18 years of age

Histologically proven squamous cell carcinoma of the head and neck (HNSCC), amenable to salvage surgery. p16 positive and negative allowed. Squamous cell carcinoma of the oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, sinonasal carcinoma and cancer of unknown primary (squamous cell carcinoma only) are all allowed. They will be allowed to have up to 3 different regimens after diagnosed of recurrent or metastatic HNSCC

Oropharyngeal tumors must have p16 or human papillomavirus (HPV) testing done

The tumor tissues must be available and banked (- 80°C) at the time of salvage surgery (1st informed consent form [ICF] must be signed)

Disqualifiers

Salivary tumors and non-squamous cell histology in head and neck cancer

Not enough tissue collected after surgery for a planned 3 doses (weight of the resectable tumor tissue is less than 1.0 gram)

Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)

Prior organ allograft or allogeneic bone marrow transplantation

Trial design

Treatments tested in this trial

  • Autologous Tumor Membrane Vesicles Vaccine
  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography
  • Magnetic Resonance Imaging
  • Pembrolizumab
  • Positron Emission Tomography
  • Surgical Procedure

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

2
Emory University Hospital Midtown30308, AtlantaGeorgia, United States
Emory University Hospital/Winship Cancer Institute30322, AtlantaGeorgia, United States

Sponsors and collaborators

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

National Institutes of Health (NIH)

Collaborator