Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07501650

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

Led by Thomas Jefferson University · Updated on 2026-03-30

6

Participants Needed

1

Research Sites

102 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pathologically confirmed HPV-negative recurrent or metastatic head and neck squamous cell carcinoma with CPS score > 1
  • Tumor lesion must be accessible by ultrasound and biopsy and measurable by RECISTv1.1 criteria
  • Male or female, 18 years of age or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Life expectancy of at least 6 months as determined by your doctor
  • Adequate organ function, including neutrophil count ≥1500/µl, platelets ≥100,000/µl, hemoglobin ≥8 g/dl, bilirubin ≤1.5 x upper normal limit, AST and ALT ≤2.5 x upper normal limit
  • 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 the last dose
  • Men who are sexually active with women of reproductive potential must use effective contraception for 90 days after the last dose unless azoospermic
  • Ability to understand and sign informed consent
Not Eligible

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 greater heart failure, unstable angina, recent heart attack within 6 months, QTc >500, or untreated ventricular arrhythmias
  • Presence of other active cancers except certain treated skin, bladder, cervical, or leukemia cancers
  • Unresolved severe toxicities from prior cancer treatments except alopecia and vitiligo
  • Recent systemic corticosteroid or immunosuppressive therapy or prior organ transplantation
  • Active autoimmune disease requiring systemic treatment in past 2 years
  • Participation in other investigational drug or device studies within 4 weeks
  • Receipt of live vaccine within 30 days prior to treatment
  • Uncontrolled illness including infections, heart failure, hypertension, angina, arrhythmias, lung disease, serious gastrointestinal conditions, or psychiatric/social issues limiting study compliance
  • Pregnant or breastfeeding
  • Active infections such as tuberculosis, hepatitis B or C, or HIV, except resolved hepatitis B or negative hepatitis C RNA
  • Untreated 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

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Trial Site Locations

Total: 1 location

1

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

J

Joseph M Curry, MD

CONTACT

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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