Actively Recruiting
TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer
Led by Emory University · Updated on 2026-03-04
40
Participants Needed
2
Research Sites
190 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Histologically confirmed head and neck squamous cell carcinoma suitable for salvage surgery
- p16 positive and negative tumors allowed, including oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, sinonasal, and cancer of unknown primary
- Oropharyngeal tumors must have p16 or HPV testing
- Tumor tissue available and banked at the time of salvage surgery
- Recurrent or metastatic HNSCC that failed standard chemotherapy and immunotherapy with progression after at least 2 prior lines
- Measurable tumors by RECIST criteria
- Sufficient tissue after surgery to make at least 3 vaccine doses (minimum 0.5 grams and >40% cellularity)
- ECOG performance status 0, 1, or 2
- Absolute neutrophil count ≥ 1,500 cells/uL
- Platelets ≥ 100,000/uL
- Hemoglobin ≥ 9.0 g/dL (transfusion allowed)
- Total bilirubin ≤ 1.5 times upper limit of normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Albumin ≥ 3.0 g/dL
- Serum creatinine ≤ 1.5 times upper limit of normal
- Calculated creatinine clearance ≥ 50 mL/min
- INR ≤ 1.5; stable anticoagulation with LMWH allowed
- Willingness and ability to comply with study procedures
- Ability to understand and sign informed consent
- Use of adequate contraception during and for 3 months after treatment for females of childbearing potential and males
- Negative pregnancy test at study entry for females of childbearing age
- Prior pembrolizumab treatment allowed
You will not qualify if you...
- Salivary gland tumors or non-squamous cell histology
- Insufficient tumor tissue after surgery for 3 vaccine doses (less than 1.0 gram)
- Treatment with chronic immunosuppressants like cyclosporine
- Prior organ transplant or allogeneic bone marrow transplant
- Active autoimmune disease or history of autoimmune disease except certain allowed conditions
- Need for systemic corticosteroids (>10mg prednisone daily) or immunosuppressants within 14 days before treatment
- Pregnant or breastfeeding women and women without adequate contraception
- Uncontrolled illnesses including HIV on therapy, active infections, severe heart conditions, unstable angina, ventricular arrhythmia, or psychiatric/social issues limiting compliance
- Other serious medical or psychiatric conditions that increase risk or interfere with study
- Bleeding disorders or coagulopathy
- Active bacterial or fungal infections requiring systemic treatment within 7 days
- Use of other investigational drugs within 28 days or 5 half-lives before study drug
- History of severe allergic reactions to monoclonal antibodies
- Receipt of non-oncology vaccines within 28 days before planned treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
D
Dong M. Shin, MD, FACP, FAAAS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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