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RecruitingPhase 1NCT06868433

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

Phase 1b Study of TMV Vaccine Therapy Alone and TMV Vaccine Plus Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Sponsor

Emory University

Enrollment

40 participants

Start Date

May 8, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Head and Neck Squamous Cell CarcinomaStage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Recurrent Head and Neck Squamous Cell CarcinomaClinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Metastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell CarcinomaStage IV Hypopharyngeal Carcinoma AJCC v8Stage IV Laryngeal Cancer AJCC v8Stage IV Lip and Oral Cavity Cancer AJCC v8Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8Recurrent Oropharyngeal Squamous Cell CarcinomaMetastatic Nasopharyngeal Squamous Cell CarcinomaMetastatic Sinonasal Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Nasopharyngeal Squamous Cell CarcinomaRecurrent Oral Cavity Squamous Cell CarcinomaRecurrent Sinonasal Squamous Cell CarcinomaSquamous Cell Carcinoma of Unknown PrimaryStage IV Nasopharyngeal Carcinoma AJCC v8Stage IV Sinonasal Cancer AJCC v8

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cancer vaccine (TMV vaccine) alone or combined with pembrolizumab (an immunotherapy drug) for patients with recurrent or metastatic head and neck squamous cell cancer who are candidates for salvage surgery. **You may be eligible if...** - You are 18 or older - You have confirmed squamous cell carcinoma of the head and neck (including oral cavity, throat, larynx, or unknown primary) - Your cancer has returned or spread and you are being considered for salvage surgery - You are in good general health (ECOG 0–1) - You have received prior systemic therapy including a PD-1/PD-L1 inhibitor **You may NOT be eligible if...** - Your cancer is metastatic to a distant organ and not surgically removable - You have active autoimmune disease - You have had recent major surgery within 28 days of enrollment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous Tumor Membrane Vesicles Vaccine

Given intradermally

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREEchocardiography

Undergo echocardiography

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALPembrolizumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET

PROCEDURESurgical Procedure

Provide tissue from standard of care surgery

Locations(2)

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

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NCT06868433

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