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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

Trying vaccine therapy and pembrolizumab for head and neck cancer.

Recruiting
18 years and older
All
Phase 1

This study is looking at a new vaccine treatment for head and neck cancer that has come back or spread. The vaccine, called TMV, is made from a person's own tumor cells. This study will test the TMV vaccine alone and with another medicine called pembrolizumab, which helps the immune system fight cancer. The study will check if the treatments are safe, what side effects they might have, and the best dose to use.

  • The study requires providing tissue from standard surgery, and includes up to 3 vaccine doses every 2 weeks.
  • Participants might also receive pembrolizumab every 3 weeks for up to a year.
  • There are regular check-ups and tests, including heart checks and blood samples.

To join, you must be at least 18, have certain types of head and neck cancer, and meet other health criteria. The study lasts about a year, with follow-ups. If you meet the requirements and are interested in new cancer treatments, this study might be an option.

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

17 October 2026

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What is a clinical trial?

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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