MedTrace Logo

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

NCT07501650 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-03-30

No results posted yet for this study

Summary

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

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

Interventions

DRUG

Pembrolizumab

Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks for up to 3 cycles

DRUG

Definity

Definity will be administered intravenously during each treatment cycle to facilitate ultrasound-induced microbubble cavitation.

DEVICE

Ultrasound-Induced Microbubble Cavitation

Therapeutic Ultrasound will be applied to the tumor site during and following the Definity infusion to induce microbubble cavitation using modified ultrasound parameters.

Sponsors & Collaborators

  • Lantheus Medical Imaging

    collaborator INDUSTRY

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Joseph M Curry, MD · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2027-03-31
Completion
2028-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07501650 on ClinicalTrials.gov