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

> **NCT06868433** · PHASE1 · RECRUITING · sponsor: **Emory University** · enrollment: 40 (estimated)

## Conditions studied

- 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

## Interventions

- **BIOLOGICAL:** Autologous Tumor Membrane Vesicles Vaccine
- **PROCEDURE:** Biospecimen Collection
- **PROCEDURE:** Computed Tomography
- **PROCEDURE:** Echocardiography
- **PROCEDURE:** Magnetic Resonance Imaging
- **BIOLOGICAL:** Pembrolizumab
- **PROCEDURE:** Positron Emission Tomography
- **PROCEDURE:** Surgical Procedure

## Key facts

- **NCT ID:** NCT06868433
- **Lead sponsor:** Emory University
- **Sponsor class:** OTHER
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-05-08
- **Primary completion:** 2028-01-31
- **Final completion:** 2028-12-31
- **Target enrollment:** 40 (ESTIMATED)
- **Last updated:** 2026-03-04

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06868433

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06868433, "TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer". Retrieved via AI Analytics 2026-06-26 from https://api.ai-analytics.org/clinical/NCT06868433. Licensed CC0.

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