A Pilot Study of Presurgical Immunotherapy with Nivolumab, Ipilimumab, and Cryoablation for Early-Stage Breast Cancer

Full Title

A Pilot Study of Pre-Operative, Single-Dose Ipilimumab, Nivolumab and Cryoablation in Early Stage/Resectable Breast Cancer

Purpose

This study is assessing the effect of a single dose of the immunotherapy drugs nivolumab and ipilimumab in addition to cryoablation given before surgery for women with newly diagnosed early-stage breast cancer. These treatments may have the potential to stimulate a patient's immune system to recognize specific features of their individual tumors and mount an attack against them. The hope is that giving this treatment in addition to surgery could boost a patient's long-term immunity against the cancer, resulting in a cure.

Patients in this study will receive a single dose of nivolumab and a single dose of ipilimumab. They will then receive cryoablation (the application of extremely cold temperatures to kill cancer cells and also stimulate an immune response). Women will have a biopsy at the time of tumor freezing to obtain tissue for analysis of the treatment's effects.

Nivolumab and ipilimumab stimulate the immune system to detect and fight cancer by blocking proteins that put the brakes on the immune response. They are both given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be women with newly diagnosed early-stage breast cancer who are planning to undergo surgery (lumpectomy or mastectomy).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Elizabeth Morris at 646-888-4510.

Protocol

16-495

Phase

Pilot

Investigator

Diseases

Locations