Feasibility Study of Pembrolizumab with Ultrasound-Triggered Microbubble Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the use of Pembrolizumab combined with ultrasound-induced microbubble cavitation in patients with recurrent or metastatic head and neck squamous cell carcinoma RM HNSCC who are HPV-negative. This feasibility trial aims to optimize the delivery of Pembrolizumab and improve tumor response. The study focuses on determining whether the treatment approach is practical by measuring recruitment success and completion of trial procedures among participants. Participants will receive up to three doses of Pembrolizumab at 200 mg intravenously every three weeks, along with Definity perflutren lipid microsphere administered intravenously during each treatment cycle. During and after Definity infusion, ultrasound will be applied to the tumor site to induce microbubble cavitation, aiming to enhance drug delivery to the tumor. Treatment is given on an outpatient basis, with the first infusion lasting about 60 minutes and subsequent infusions approximately 30 minutes each. After treatment, participants will be followed for safety for three months. Throughout the study, participants will undergo clinical and radiographic assessments to evaluate tumor response, overall survival, and progression-free survival. Researchers will monitor serious adverse events and collect various biological and imaging data to study immune cell populations and inflammatory markers within tumors. The primary outcome is the number of participants who complete all planned treatment cycles within nine weeks. Safety and treatment effects will be tracked for up to six months after treatment ends. Total participation lasts through treatment and follow-up periods, with detailed evaluations at regular visits.

Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer