Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer
Trial Parameters
Brief Summary
This is a feasibility trial studying anti-PD-1 therapy (Pembrolizumab) among patients with R/M HNSCC, delivered with ultrasound-induced microbubble cavitation, with the goal of optimizing delivery of Pembrolizumab and tumor response to Pembrolizumab. Patients will undergo 3 infusions of Pembrolizumab plus Definity 3 weeks apart. Following each infusion, ultrasound will be directed at the primary tumor site to induce microbubble cavitation, with the goal of tumor sonoporation. The primary endpoints will be feasibility, measured based on successful recruitment of 6 participants within 1 year of initiating recruitment, with successful completion of trial procedures among at least 80 percent of patients. Secondary endpoints will include proportion of serious adverse events, clinical/radiographic response, overall survival, and progression-free survival.
Eligibility Criteria
Inclusion Criteria: * Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: 1. Pathologically confirmed, HPV-negative, R/M HNSCC per American Joint Committee on Cancer (AJCC) 8th Edition Staging Criteria, with CPS score \> 1 2. The target lesion is ultrasound-accessible, biopsy-accessible, and measurable in at least one dimension, based on RECISTv1.1 criteria. 3. Male or female, aged ≥18 years of age 4. ECOG Performance status 0-2. 5. Must have a life expectancy of at least 6 months as judged by the treating physician. 6. Adequate organ function: 1. Absolute neutrophil count 1500/μl or more; 2. Platelets 100,000/μl or more, 3. Hemoglobin 8 g/dl or more; 4. Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin \<3 mg/dl); 5. AST and ALT less than or equal to 2.5x the upper limit of normal 7. Women of reproductive potential should have a negative ser