Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Eileen Connolly
Study ID
NCT02977468
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Merck 3475 Pembrolizumab — DRUG
    Participants receive Pembrolizumab by vein over about 30 minutes on Day 1 of one to two cycles.
  • Intraoperative radiation therapy (IORT) — RADIATION
    Participants will receive Intraoperative radiation therapy (IORT) on the day of surgery.

Study Details

Assess response to pembrolizumab in both primary tumor, normal breast stroma, circulating lymphocytes and serum exosomes in treatment naive triple negative breast cancer (TNBC) patients. Assess for change in tumor-infiltrating lymphocytes (TILS) both stromal (sTILS) and intraepithelial (iTILS) in newly diagnosed early stage TNBC patients treated with two doses of MK-3475 prior to lumpectomy.

Key Dates

Start date
Oct 25, 2017
Status verified
Jun 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm open label
    Participants receive 'Merck 3475 Pembrolizumab' by vein one to two times before Intraoperative radiation therapy (IORT). The Intrabeam® Photon Radiosurgery System is a miniature electron beam-driven X-ray source which provides a point source of low energy X-rays (50 kV maximum) at the tip of a 3.2 mm diameter tube. The radiation source can be inserted into the area of interest immediately after excision of the tumor and switched on for 20-35 minutes to provide intraoperative radiotherapy accurately targeted to the tissues that are at the highest risk of local recurrence. The dosimetric characteristics and early clinical applications of this device have been well studied and this is the device which was utilized in the international TARGIT trial.

Primary Outcome Measure

Number of subjects with significant mean percent change in TILs [ Time Frame: 3 months ]

Central Contacts

  • Eileen Connolly, MD
    212-305-5050
    [email protected]
  • Radiation Oncology Research Department
    212-305-5050

Locations (3)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Jane Meisel, MD
Loyola University ChicagoMaywoodIllinois60153
William Small, MD
Columbia University Irving Medical CenterNew YorkNew York10032
Eileen Connolly, MD
[email protected]
212-305-5050
Mariamne Reyna
[email protected]
646-317-4244
Eileen Connolly, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Emory University· Atlanta, GALoyola University Chicago· Maywood, ILColumbia University Irving Medical Center· New York, NY

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