NCT06868433View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

May 8, 2025

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2027

Conditions
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Metastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Nasopharyngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaMetastatic Sinonasal Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Nasopharyngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal Squamous Cell CarcinomaRecurrent Sinonasal Squamous Cell CarcinomaSquamous Cell Carcinoma of Unknown PrimaryStage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Nasopharyngeal Carcinoma AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Stage IV Sinonasal Cancer AJCC v8
Interventions
BIOLOGICAL

Autologous Tumor Membrane Vesicles Vaccine

Given intradermally

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography

Undergo echocardiography

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET

PROCEDURE

Surgical Procedure

Provide tissue from standard of care surgery

Trial Locations (2)

30308

RECRUITING

Emory University Hospital Midtown, Atlanta

30322

RECRUITING

Emory University Hospital/Winship Cancer Institute, Atlanta

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Emory University

OTHER