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

Summary

This phase Ib trial tests the safety, side effects and best dose of tumor membrane vesicle (TMV) vaccine therapy alone and in combination with pembrolizumab and evaluates how well it works in treating patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Vaccines made from a person's tumor cells, such as TMV vaccines, may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving TMV vaccine therapy alone or with pembrolizumab may be safe, tolerable and/or effective in treating patients with recurrent and/or metastatic head and neck squamous cell cancer.

Conditions

• 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

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Emory University

  lead OTHER

Principal Investigators

• Dong M. Shin, MD, FACP, FAAAS · Emory University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-08

Primary Completion

2028-01-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations