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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 head and neck cancer.

Recruiting
18 years and older
All
Phase 1

This study is testing a new treatment for head and neck cancer that's come back or spread. It uses a TMV vaccine made from a patient's own tumor cells. The vaccine might help your body fight the cancer by making your immune system stronger. The study also uses a drug called pembrolizumab, which is an immunotherapy drug that helps the immune system attack cancer cells.

In this study, patients are split into two groups: one group gets only the TMV vaccine, and the other gets both the TMV vaccine and pembrolizumab. The study checks if this approach is safe and effective. Patients will have regular checkups, including scans and blood tests.

  • Study involves regular visits every few weeks for up to a year.
  • Participants must be 18 or older and have specific types of head and neck cancer.
  • The study provides close monitoring of health and may involve some risks and side effects.

After the treatment, patients are monitored for up to 12 months to see how well the treatment works. Participants should be willing to commit to the study schedule and procedures.

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

23 August 2025

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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.

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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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