OncoMatch/Clinical Trials/NCT07501650
Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer
Is NCT07501650 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Pembrolizumab and Definity for head and neck cancer.
Treatment: Pembrolizumab · Definity · Ultrasound-Induced Microbubble Cavitation — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV negative
HPV-negative
Required: CDKN2A p16-negative
p16-negative
Required: PD-L1 (CD274) CPS score > 1 (CPS > 1)
CPS score > 1
Disease stage
Metastatic disease required
R/M HNSCC per American Joint Committee on Cancer (AJCC) 8th Edition Staging Criteria, with CPS score > 1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-PD-1 therapy
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or antiCTLA-4 antibody
Lab requirements
Blood counts
Absolute neutrophil count ≥1500/μl; Platelets ≥100,000/μl; Hemoglobin ≥8 g/dl
Liver function
Bilirubin ≤ 1.5 x ULN (except Gilbert syndrome <3 mg/dl); AST and ALT ≤ 2.5x ULN
Adequate organ function: Absolute neutrophil count 1500/μl or more; Platelets 100,000/μl or more; Hemoglobin 8 g/dl or more; Bilirubin ≤ 1.5 x ULN (except Gilbert syndrome, <3 mg/dl); AST and ALT ≤ 2.5x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Philadelphia, Pennsylvania
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