Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
150

Summary

Conditions
Breast Cancer
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

The purpose of this study is to determine the impact of pre-operative cryoablation, ipilimumab and nivolumab on 3-year Event Free Survival (EFS), in women with triple negative breast cancer after taxane-based neoadjuvant chemotherapy. Our strategy combines two interventions: induced activation and m...

The purpose of this study is to determine the impact of pre-operative cryoablation, ipilimumab and nivolumab on 3-year Event Free Survival (EFS), in women with triple negative breast cancer after taxane-based neoadjuvant chemotherapy. Our strategy combines two interventions: induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens via local destruction of tumor tissue by cryoablation. Second, we administer ipilimumab, a CTLA4 blocking antibody that enhances the magnitude and potency of the tumor specific T cell response, with nivolumab, a PD-1 blocking antibody that interferes with PD-1 mediated T-cell regulatory signaling. Women with residual triple negative resectable breast cancer after neoadjuvant chemotherapy will be treated with tumor cryoablation and pre-operative nivolumab and ipilimumab followed post-operative nivolumab. Women undergoing either mastectomy or breast conserving surgery are eligible.

Tracking Information

NCT #
NCT03546686
Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Heather McArthur, MD, MPH Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute