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Study identifier: NCT06868433 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer

Condition: Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Metastatic Head and Neck Squamous Cell Carcinoma · Metastatic Hypopharyngeal Squamous Cell Carcinoma  ·  Sponsor: Emory University

PhasePhase 1
Planned participants40
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Dong M. Shin, MD, FACP, FAAAS  ·  404-778-2980  ·  dmshin@emory.edu

Always discuss trial participation with your own doctor first.

Locations (2)

Emory University Hospital MidtownAtlanta, Georgia, United StatesRecruiting
Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06868433