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Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer (Breast-48)

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ClinicalTrials.gov Identifier: NCT03237572
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):

July 31, 2017
August 2, 2017
September 26, 2017
September 25, 2017
September 16, 2019   (Final data collection date for primary outcome measure)
Change in tumor infiltrating lymphocytes [ Time Frame: baseline and week 4 ]
Change in proportion of CD8+ tumor infiltrating lymphocytes (ration CD8+/CD4+) in the primary ablation zone
Same as current
Complete list of historical versions of study NCT03237572 on ClinicalTrials.gov Archive Site
Adverse event profile of pembrolizumab and HIFU [ Time Frame: From date of randomization through 30 days following cessation of treatment ]
Toxicities from the combination of pembrolizumab and HIFU
Same as current
Not Provided
Not Provided
 
Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer
Focused Ultrasound Therapy to Augment Antigen Presentation and Immune-Specificity of Checkpoint Inhibitor Therapy With Pembrolizumab in Metastatic Breast Cancer
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pilot, 2-arm randomized study
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Pembrolizumab
    Pembrolizumab (200 mg)
    Other Name: Keytruda
  • Device: High-intensity focused ultrasound (HIFU)
    Ablation will target 50% of the tumor, up to 3 cubic centimeters
  • 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.
    Interventions:
    • Drug: Pembrolizumab
    • Device: High-intensity focused ultrasound (HIFU)
  • 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.
    Interventions:
    • Drug: Pembrolizumab
    • Device: High-intensity focused ultrasound (HIFU)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
November 25, 2021
September 16, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria (summary):

  • Histologically confirmed metastatic or unresectable breast cancer
  • Any receptor status (estrogen receptor, progesterone receptor, HER2 receptor). Patients who are HR+ should also no longer be candidates for hormonal-based therapy. Patients who are HER2+ should have progressed on or no longer be candidates for available HER2 directed therapy. Hormonal therapy must be stopped prior to day 1 of treatment.
  • Patients must have had at least one prior line of therapy for breast cancer in the metastatic setting.
  • Patients must have an accessible lesion in the breast/chest wall/axilla which has not been previously thermally ablated. Prior breast irradiation is acceptable if the lesion has recurred or grown following radiation.
  • Patients must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication.
  • Patients must have at least one target lesion in breast/chest wall/axilla which is amenable to application of high intensity focused ultrasound:
  • Patients must be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
  • Performance status of 0 or 1 on the ECOG Performance Scale.
  • Adequate organ function

Exclusion Criteria (summary):

  • Patients currently participating and receiving study therapy or patients who have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Patients with a diagnosis of immunodeficiency, patients receiving systemic steroid therapy or, patients who have received any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Patients with a known history of active Tuberculosis
  • Hypersensitivity to pembrolizumab or any of its excipients
  • Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1. Patients who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier are excluded.
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1. Patients who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Active infection requiring systemic therapy.
  • Pregnancy
  • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent within the prior 24 weeks.
  • Known history of Human Immunodeficiency Virus (HIV)
  • Receipt of a live vaccine within 30 days of planned start of study therapy.
  • Breast implant on the side of the body that will receive HIFU application
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Jessica Zareno, MS 434-982-1901 jhz4f@virginia.edu
Contact: Alexandra Carney, MPH 434-982-6714 alc6a@virginia.edu
United States
 
 
NCT03237572
19900
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Not Provided
Patrick Dillon, MD, University of Virginia
Patrick Dillon, MD
Not Provided
Principal Investigator: Patrick Dillon, MD University of Virginia
University of Virginia
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP