Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07501650 | Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer | PHASE1 | RECRUITING | 6 | — | — | Mar 18, 2026 | Mar 1, 2028 | Mar 30, 2026 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Pembro + Ultrasound-Induced Microbubble Cavitation | EXPERIMENTAL | Treatment will be administered on an outpatient basis. 200 mg Pembrolizumab + 3 mL Definity infusions will be administered by nurses at Thomas Jefferson University every 3 weeks for up to 3 cycles. The first cycle will take 60 minutes, while the subsequent infusions should take half an hour to complete. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks for up to 3 cycles |
| Definity | DRUG | Definity will be administered intravenously during each treatment cycle to facilitate ultrasound-induced microbubble cavitation. |
| Ultrasound-Induced Microbubble Cavitation | DEVICE | Therapeutic Ultrasound will be applied to the tumor site during and following the Definity infusion to induce microbubble cavitation using modified ultrasound parameters. |
Inclusion Criteria: * Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: 1. Pathologically confirmed, HPV-negative, R/M HNSCC per American Joint Committee on Cancer (AJCC) 8th Edition Staging Criteria, with CPS score \> 1 2. The t...