๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-03-24

Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer (NCT07501650)

Feasibility Trial of Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

๐ŸŸข Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Thomas Jefferson University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University โ€” Philadelphia, Pennsylvania

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University โ€” Philadelphia, Pennsylvania

๐Ÿ“ž Contact the Study Coordinator

Phone: (215) 955-6760

Email: Joseph.Curry@jefferson.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—