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

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

Trial Details

NCT ID

NCT06868433

Phase

PHASE1

Sponsor

Emory University

Status

RECRUITING

Cancer Type

HPV Positive Head and Neck Cancer

Interventions

Autologous Tumor Membrane Vesicles Vaccine
Biospecimen Collection
Computed Tomography
Echocardiography
Magnetic Resonance Imaging
Pembrolizumab

Locations (sample)

Atlanta, Georgia, United States|33.749,-84.38798
Atlanta, Georgia, United States|33.749,-84.38798

Key Eligibility Criteria

Must be at least ≥ 18 years of age
Histologically proven squamous cell carcinoma of the head and neck (HNSCC), amenable to salvage surgery. p16 positive and negative allowed. Squamou…
Oropharyngeal tumors must have p16 or human papillomavirus (HPV) testing done
The tumor tissues must be available and banked (- 80°C) at the time of salvage surgery (1st informed consent form \[ICF\] must be signed)

For full eligibility, visit ClinicalTrials.gov.

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