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
Locations
2Sponsors and collaborators
Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
National Institutes of Health (NIH)
Collaborator