Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 12, 2019

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2028

Conditions
Breast Cancer
Interventions
DRUG

Pembrolizumab

Pembro will be administered 1-20 days before the cryoablation date per SOC and q3 weeks after surgery for 9 cycles per SOC.

PROCEDURE

Core Biopsy/Cryoablation

US-guided core biopsy and cryoablation 7-10 days prior to surgery.

PROCEDURE

Breast Surgery

Standard-of-care definitive surgery.

DRUG

Ipilimumab

ipilimumab 1mg/Kg IV is administered 1-5 days prior to cryoablation.

DRUG

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.

Trial Locations (4)

43210

RECRUITING

Ohio State University Medical Center, Columbus

75390

RECRUITING

UT Southwestern Medical Center, Dallas

90048

ACTIVE_NOT_RECRUITING

Cedars Sinai Medical Center, Los Angeles

97213

ACTIVE_NOT_RECRUITING

Providence Cancer Institute, Portland

All Listed Sponsors
collaborator

Susan G. Komen Breast Cancer Foundation

OTHER

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Boston Scientific Corporation

INDUSTRY

collaborator

American Society of Clinical Oncology

OTHER

lead

University of Texas Southwestern Medical Center

OTHER