Actively Recruiting
Feasibility Trial of Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Led by Thomas Jefferson University · Updated on 2026-03-30
6
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
Thomas Jefferson University
Lead Sponsor
L
Lantheus Medical Imaging
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Pembrolizumab combined with ultrasound-induced microbubble cavitation in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) who are HPV-negative. This feasibility trial aims to optimize the delivery of Pembrolizumab and improve tumor response. The study focuses on determining whether the treatment approach is practical by measuring recruitment success and completion of trial procedures among participants. Participants will receive up to three doses of Pembrolizumab at 200 mg intravenously every three weeks, along with Definity perflutren lipid microsphere administered intravenously during each treatment cycle. During and after Definity infusion, ultrasound will be applied to the tumor site to induce microbubble cavitation, aiming to enhance drug delivery to the tumor. Treatment is given on an outpatient basis, with the first infusion lasting about 60 minutes and subsequent infusions approximately 30 minutes each. After treatment, participants will be followed for safety for three months. Throughout the study, participants will undergo clinical and radiographic assessments to evaluate tumor response, overall survival, and progression-free survival. Researchers will monitor serious adverse events and collect various biological and imaging data to study immune cell populations and inflammatory markers within tumors. The primary outcome is the number of participants who complete all planned treatment cycles within nine weeks. Safety and treatment effects will be tracked for up to six months after treatment ends. Total participation lasts through treatment and follow-up periods, with detailed evaluations at regular visits.
CONDITIONS
Brief Title
Pembrolizumab Plus Ultrasound-Induced Microbubble Cavitation in Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed HPV-negative recurrent or metastatic head and neck squamous cell carcinoma with CPS score greater than 1
- Target lesion must be accessible by ultrasound and biopsy, and measurable by RECIST v1.1 criteria
- Male or female aged 18 years or older
- ECOG performance status of 0 to 2
- Life expectancy of at least 6 months
- Adequate organ function including neutrophil count ≥1500/µl, platelets ≥100,000/µl, hemoglobin ≥8 g/dl, bilirubin ≤1.5 times upper limit of normal (except Gilbert syndrome), and AST/ALT ≤2.5 times upper limit of normal
- Women of reproductive potential must have a negative pregnancy test within 28 days before starting treatment
- Women of reproductive potential must use effective contraception for 90 days after last dose
- Men of reproductive potential who are sexually active with women of reproductive potential must use contraception with failure rate less than 1% for 90 days after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- HPV-positive or p16-positive squamous cell carcinoma
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies
- Allergy to study drug components including polyethylene glycol
- History of certain cardiac conditions including right-to-left cardiac shunts, NYHA class III or higher heart failure, unstable angina, recent heart attack within 6 months, QTc >500, or uncorrected ventricular arrhythmia
- Concurrent malignancies except specific low-risk cancers or disease-free for 2 years post-treatment
- Unresolved toxicity grade 2 or higher from prior anticancer therapy (except alopecia, vitiligo)
- Systemic corticosteroid or immunosuppressive treatment within 28 days before study drug or prior allogenic organ transplantation
- Active autoimmune disease requiring systemic treatment in past 2 years
- Use of other investigational agents within 4 weeks before study drug
- Receipt of live attenuated vaccine within 30 days before study drug
- Uncontrolled illness including infection, heart failure, hypertension, angina, arrhythmia, lung disease, serious gastrointestinal conditions, or psychiatric illness limiting compliance
- Pregnant or breastfeeding women
- Active infections including tuberculosis, hepatitis B or C (with exceptions), or HIV
- Untreated or active brain metastases
- History of pneumonitis within past 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 weeks
Participants receive up to 3 cycles of Pembrolizumab and Definity infusions with ultrasound-induced microbubble cavitation targeting the tumor site. The first treatment cycle lasts about 60 minutes, and subsequent cycles take approximately 30 minutes each. Treatment cycles occur every 3 weeks on an outpatient basis.
Up to 3 outpatient visits, one every 3 weeks
Duration - 3 months
Participants are monitored for safety and treatment response for 3 months after the last treatment cycle.
Periodic follow-up visits up to 3 months post-treatment
Trial Site Locations
Total: 1 location
1
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
J
Joseph M Curry, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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