Actively Recruiting
Phase 1b Study of TMV Vaccine Therapy Alone and TMV Vaccine Plus Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
Led by Emory University · Updated on 2026-03-04
40
Participants Needed
2
Research Sites
47 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
Researchers are studying tumor membrane vesicle (TMV) vaccine therapy alone and combined with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell cancer. This phase Ib trial aims to evaluate the safety, side effects, best dose, immune response, tumor response, progression-free survival, and overall survival. The study also explores tumor characteristics and immune activity using next-generation sequencing on tumor samples and blood cells. Patients provide tumor tissue from standard surgery to create the vaccine, which is stored for future use. The study has two groups: one receives TMV vaccine alone intradermally every two weeks for up to three doses, while the other receives the same vaccine plus pembrolizumab intravenously every three weeks for up to one year if no disease progression or severe side effects occur. Echocardiography, blood samples, and imaging scans like CT, MRI, or PET are performed during the study. Participants undergo baseline and end-of-treatment heart ultrasounds and regular blood tests throughout the trial. They may have additional imaging to monitor disease. After treatment, patients are followed for up to 12 months with visits every three weeks. The study measures dose-limiting toxicities, treatment side effects, immune response, tumor shrinkage, and survival outcomes over the treatment and follow-up periods.
CONDITIONS
Brief 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 squamous cell carcinoma of the head and neck suitable for salvage surgery
- Oropharyngeal tumors must have p16 or HPV testing
- Tumor tissue available and banked at salvage surgery
- Recurrent and/or metastatic disease progressed after at least 2 lines of standard therapy
- Tumors measurable by RECIST criteria
- Tumor tissue sufficient to make at least 3 vaccine doses (minimum 0.5 grams, >40% cellularity)
- ECOG performance status 0, 1, or 2
- Adequate blood counts and organ function as specified
- Willingness and ability to comply with study visits and procedures
- Ability to understand and sign informed consent
- Use of contraception during and 3 months after treatment for males and females of childbearing potential
- Negative pregnancy test for females of childbearing age
- Prior pembrolizumab treatment allowed
You will not qualify if you...
- Salivary tumors or non-squamous cell head and neck cancers
- Insufficient tumor tissue collected for vaccine production (<1.0 gram)
- Chronic immunosuppressant treatment
- Prior organ or bone marrow transplant
- Active autoimmune disease except certain controlled conditions
- Recent systemic corticosteroids or immunosuppressive medications
- Pregnant or lactating women without adequate contraception
- Uncontrolled illnesses including active infections or severe heart conditions
- Conditions or medications increasing risk or interfering with study participation
- Bleeding disorders
- Recent active infections requiring systemic treatment
- Use of other investigational drugs within 28 days
- History of severe reactions to monoclonal antibodies
- Receipt of non-oncology vaccines within 28 days prior to treatment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year depending on cohort and disease progression
Participants receive TMV vaccine intradermally once every 2 weeks for up to 3 doses. Participants in Cohort 2 also receive pembrolizumab intravenously on day 1 of each 3-week cycle, continuing for up to 1 year if disease does not progress or unacceptable toxicity occurs. Echocardiography is performed at baseline and at the end of treatment, with blood samples collected throughout the study. Additional imaging such as CT, MRI, or PET may also occur during treatment.
Up to 3 vaccine visits every 2 weeks; pembrolizumab IV on day 1 of each 3-week cycle for up to 1 year; echocardiography at baseline and end of treatment; blood samples collected throughout; additional imaging visits as needed
Duration - Up to 12 months
After completion of study treatment, participants are followed up on day 90 and then every 3 weeks for up to 12 months to monitor health and disease status.
Visits every 3 weeks after day 90 for up to 12 months
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
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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