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

Exploring new treatments for recurring/metastatic head and neck cancer.

Recruiting
18 years and older
All
Phase 1

This study is looking at a new way to treat head and neck squamous cell cancer (HNSCC) that has come back or spread. It uses a special vaccine called tumor membrane vesicle (TMV) vaccine that helps the body fight the cancer. Some patients will also get a medicine called pembrolizumab, which helps the immune system attack cancer cells.

Who Can Join: You must be at least 18, have a type of head and neck cancer, and have gone through certain treatments before. Your cancer must have come back or spread, and you need to have enough tumor tissue saved from surgery to make the vaccines.

  • The study lasts up to 1 year, with visits every 3 weeks.
  • You'll get either the TMV vaccine alone or with pembrolizumab.
  • Expect regular tests like blood samples, scans, and heart checks.

After treatment, there are follow-up visits for up to 12 months. This study aims to find the best dose and see how well the treatment works. Before joining, make sure you're okay with the procedures and understand the possible risks and benefits.

Study details
    Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
    Metastatic Head and Neck Squamous Cell Carcinoma
    Metastatic Hypopharyngeal Squamous Cell Carcinoma
    Metastatic Laryngeal Squamous Cell Carcinoma
    Metastatic Nasopharyngeal Squamous Cell Carcinoma
    Metastatic Oral Cavity Squamous Cell Carcinoma
    Metastatic Oropharyngeal Squamous Cell Carcinoma
    Metastatic Sinonasal Squamous Cell Carcinoma
    Recurrent Head and Neck Squamous Cell Carcinoma
    Recurrent Hypopharyngeal Squamous Cell Carcinoma
    Recurrent Laryngeal Squamous Cell Carcinoma
    Recurrent Nasopharyngeal Squamous Cell Carcinoma
    Recurrent Oral Cavity Squamous Cell Carcinoma
    Recurrent Oropharyngeal Squamous Cell Carcinoma
    Recurrent Sinonasal Squamous Cell Carcinoma
    Squamous Cell Carcinoma of Unknown Primary
    Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
    Stage IV Hypopharyngeal Carcinoma AJCC v8
    Stage IV Laryngeal Cancer AJCC v8
    Stage IV Lip and Oral Cavity Cancer AJCC v8
    Stage IV Nasopharyngeal Carcinoma AJCC v8
    Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
    Stage IV Sinonasal Cancer AJCC v8

NCT06868433

Emory University

2 May 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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