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NCT07501650 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer
A Phase 1 study, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT07501650 is a Phase 1 study that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 6 participants.
The verdict
NCT07501650, a Phase 1 study, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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.
Interventions
- DRUG Pembrolizumab
- DRUG Definity
- DEVICE Ultrasound-Induced Microbubble Cavitation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2026-03-18 |
| Est. Completion | 2028-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07501650
The ClinicalTrials.gov registry entry for NCT07501650 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT07501650 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07501650 about?
NCT07501650 is a clinical study titled "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 Pembrolizuma...
What is the current status of trial NCT07501650?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2026-03-18. Estimated completion is 2028-03.
What interventions are being tested in trial NCT07501650?
The interventions under investigation include: Pembrolizumab (DRUG), Definity (DRUG), Ultrasound-Induced Microbubble Cavitation (DEVICE).
Who is sponsoring clinical trial NCT07501650?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
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