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

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

Trial Details

NCT ID
NCT07501650
Phase
PHASE1
Sponsor
Thomas Jefferson University
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Pembrolizumab
  • Definity
  • Ultrasound-Induced Microbubble Cavitation
Locations (sample)
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility Criteria

  • Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
  • 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

For full eligibility, visit ClinicalTrials.gov.

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