ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 119 for:    focused ultrasound | Recruiting, Not yet recruiting, Available Studies

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03237572
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Patrick Dillon, MD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Pembrolizumab Device: High-intensity focused ultrasound (HIFU) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot, 2-arm randomized study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Focused Ultrasound Therapy to Augment Antigen Presentation and Immune-Specificity of Checkpoint Inhibitor Therapy With Pembrolizumab in Metastatic Breast Cancer
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : September 16, 2019
Estimated Study Completion Date : November 25, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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 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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237572


Contacts
Contact: Jessica Zareno, MS 434-982-1901 jhz4f@virginia.edu
Contact: Meagan Darling 434-982-6584 mtd6wa@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Jessica Zareno, MS    434-982-1901    jhz4f@virginia.edu   
Contact: Alexandra Carney, MPH    434-982-6714    alc6a@virginia.edu   
Sponsors and Collaborators
Patrick Dillon, MD
Investigators
Principal Investigator: Patrick Dillon, MD University of Virginia

Responsible Party: Patrick Dillon, MD, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT03237572     History of Changes
Other Study ID Numbers: 19900
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

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

Keywords provided by Patrick Dillon, MD, University of Virginia:
breast cancer
pembrolizumab
focused ultrasound
immunotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pembrolizumab
Antineoplastic Agents