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Clinical Trial Summary

The purpose of this study is to determine the impact of pre-operative cryoablation, ipilimumab and nivolumab versus standard pre-operative care on on 3-year Event Free Survival (EFS), in women with residual hormone receptor negative, HER2-negative ("triple negative") resectable breast cancer after taxane-based neoadjuvant chemotherapy.

Clinical Trial Description

The purpose of this study is to determine the impact of pre-operative cryoablation, ipilimumab and nivolumab versus standard pre-operative care on 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 randomized to standard peri-operative management versus tumor cryoablation with pre-operative nivolumab and ipilimumab followed post-operative nivolumab. Women undergoing either mastectomy or breast conserving surgery are eligible. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03546686
Study type Interventional
Source Cedars-Sinai Medical Center
Contact Christina Abaya
Phone 310-423-5489
Status Recruiting
Phase Phase 2
Start date February 2019
Completion date May 2023

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