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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 : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Patrick Dillon, MD, University of Virginia

Tracking Information
First Submitted Date  ICMJE July 31, 2017
First Posted Date  ICMJE August 2, 2017
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE September 25, 2017
Estimated Primary Completion Date September 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03237572 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer
Official Title  ICMJE Focused Ultrasound Therapy to Augment Antigen Presentation and Immune-Specificity of Checkpoint Inhibitor Therapy With Pembrolizumab in Metastatic Breast Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pilot, 2-arm randomized study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2017)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 25, 2021
Estimated Primary Completion Date September 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rachael Reed 434-982-6584 RMR3BX@virginia.edu
Contact: Emily Allred, PhD 434-982-1902 eh4m@virginia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03237572
Other Study ID Numbers  ICMJE 19900
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patrick Dillon, MD, University of Virginia
Study Sponsor  ICMJE Patrick Dillon, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patrick Dillon, MD University of Virginia
PRS Account University of Virginia
Verification Date May 2019

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