Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
Patrick Dillon, MD
Study ID
NCT03237572
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab (200 mg)
  • High-intensity focused ultrasound (HIFU) — DEVICE
    Ablation will target 50% of the tumor, up to 3 cubic centimeters

Study Details

This pilot study evaluates the use of high-intensity focused ultrasound (HIFU) combined with pembrolizumab in patients with metastatic breast cancer. One-half of participants will be randomized to receive the first dose of pembrolizumab after HIFU and one-half of participants will be randomized to receive their first dose of pembrolizumab before HIFU.

Key Dates

Start date
Sep 25, 2017
Status verified
Jan 2026
Primary completion
Jun 1, 2022
Completion
Jun 17, 2022

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: 1st dose of pembrolizumab after HIFU
    Pembrolizumab (200 mg) administered intravenously, days 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.
  • Experimental: Arm B: 1st dose of pembrolizumab before HIFU
    Pembrolizumab (200 mg) intravenously, days 1, 22, 43, 64, followed by day 1 of each ensuing 3 -week cycle. Focused ultrasound tumor ablation day 15. High-intensity focused ultrasound ablation will target 50% of the tumor, up to 3 cubic centimeters.

Primary Outcome Measure

Change in Proportion of CD8+ Tumor Infiltrating Lymphocytes [ Time Frame: baseline and week 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908-

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Find similar trials in Charlottesville, VA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Virginia· Charlottesville, VA

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