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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07501650
Phase
PHASE1
Status
Recruiting
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Conditions

  • Head and Neck Cancer
  • Head and Neck Small Cell Carcinoma
  • Metastatic Head and Neck Cancer
  • Recurrent Head and Neck Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 18, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Pembro + Ultrasound-Induced Microbubble Cavitation
    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.

Primary Outcome Measure

Number of Participants who complete all planned treatment cycles [ Time Frame: Up to 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Joseph Curry, MD
[email protected]
(215) 955-6760

Find similar trials in Philadelphia, PA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University· Philadelphia, PA

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