Phase 1b Study of TMV Vaccine Therapy Alone and Combined with Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are studying tumor membrane vesicle TMV vaccine therapy alone and combined with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell cancer. This phase Ib trial aims to evaluate the safety, side effects, best dose, immune response, tumor response, progression-free survival, and overall survival. The study also explores tumor characteristics and immune activity using next-generation sequencing on tumor samples and blood cells. Patients provide tumor tissue from standard surgery to create the vaccine, which is stored for future use. The study has two groups one receives TMV vaccine alone intradermally every two weeks for up to three doses, while the other receives the same vaccine plus pembrolizumab intravenously every three weeks for up to one year if no disease progression or severe side effects occur. Echocardiography, blood samples, and imaging scans like CT, MRI, or PET are performed during the study. Participants undergo baseline and end-of-treatment heart ultrasounds and regular blood tests throughout the trial. They may have additional imaging to monitor disease. After treatment, patients are followed for up to 12 months with visits every three weeks. The study measures dose-limiting toxicities, treatment side effects, immune response, tumor shrinkage, and survival outcomes over the treatment and follow-up periods.

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