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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: Recruiting Phase 1 study, sponsored by Thomas Jefferson University.
NCT07501650 is a Phase 1 study that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The number of participants who completed trial procedures among at least 80 percent of patients, among patients with recurrent or metastatic head and neck squamous cell carcinoma.
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 |
What NCT07501650 shows while recruiting
NCT07501650 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT07501650 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07501650's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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