80
Participants
Start Date
November 12, 2019
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2028
Pembrolizumab
Pembro will be administered 1-20 days before the cryoablation date per SOC and q3 weeks after surgery for 9 cycles per SOC.
Core Biopsy/Cryoablation
US-guided core biopsy and cryoablation 7-10 days prior to surgery.
Breast Surgery
Standard-of-care definitive surgery.
Ipilimumab
ipilimumab 1mg/Kg IV is administered 1-5 days prior to cryoablation.
Nivolumab
nivolumab 240mg IV flat dose is administered 1-5 days prior to cryoablation and 240mg IV every 2 weeks ± 3 days starting 3 (+/-1) weeks after surgery.
RECRUITING
Ohio State University Medical Center, Columbus
RECRUITING
UT Southwestern Medical Center, Dallas
ACTIVE_NOT_RECRUITING
Cedars Sinai Medical Center, Los Angeles
ACTIVE_NOT_RECRUITING
Providence Cancer Institute, Portland
Collaborators (2)
Susan G. Komen Breast Cancer Foundation
OTHER
Bristol-Myers Squibb
INDUSTRY
Boston Scientific Corporation
INDUSTRY
American Society of Clinical Oncology
OTHER
University of Texas Southwestern Medical Center
OTHER