Ultrasound Microbubble Cavitation + Pembrolizumab

Therapeutic Ultrasound will be applied to the tumor site during and following the Definity infusion to induce microbubble cavitation using modified ultrasound parameters.

Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks for up to 3 cycles

The proposed study is a feasibility trial of Pembrolizumab plus Definity Perflutren Lipid Microsphere (Lantheus Medical Imaging), followed by ultrasound-induced microbubble cavitation (UC), which will target patients with R/M HNSCC, for which Pembrolizumab is already indicated as standard of care treatment. Patients will undergo up to 3 cycles of therapy.

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.

Live record on ClinicalTrials.gov →

• Pathologically confirmed, HPV-negative, R/M HNSCC per American Joint Committee on Cancer (AJCC) 8th Edition Staging Criteria, with CPS score > 1
• The target lesion is ultrasound-accessible, biopsy-accessible, and measurable in at least one dimension, based on RECISTv1.1 criteria.
• Male or female, aged ≥18 years of age
• ECOG Performance status 0-2.
• Must have a life expectancy of at least 6 months as judged by the treating physician.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.