Breast Cancer

NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-Negative Breast Cancer

Appointment New Patient Appointment or 214-645-8300

Study Overview

The purpose of this research study is to determine how two drugs together – nivolumab and ipilimumab – work in treating breast cancer that has spread to other parts of the body. The investigators also want to understand whether certain DNA or protein markers in the blood or tumor tissue may indicate whether the combination will work in future patients.

Nivolumab is called an anti-PD-1 or a checkpoint inhibitor and is an antibody designed to allow the body's own immune system to destroy tumors. Ipilimumab is called an anti-CTLA-4 and is a type of antibody that works to prevent your body's immune system from stopping to fight this specific cancer.

We seek patients who have either triple negative breast cancer or hormone receptor positive breast cancer with more than 10 mutations per megabase of DNA as determined on molecular testing report (such as through Foundation Medicine, TEMPUS, Caris testing, etc.) that has spread to other parts of the body and has not yet been treated or has been treated but not responded.

Study Details

This is a study for hypermutated HER2 negative breast cancer (either triple negative breast cancer or hormone receptor positive breast cancer that has ≥10 mutations/megabase) that has spread to other parts of the body and hasn’t been treated yet, or has been treated but has not responded to the treatment. 

Hypermutated tumors are tumors that have developed many mutations within the genes that encode them. This may result in these tumors potentially being more sensitive to immunotherapy than other tumors.

This research study is studying a drug combination of nivolumab and ipilimumab as a possible treatment for this diagnosis. Nivolumab is called an anti- PD-1 or a checkpoint inhibitor and is an antibody, a type of human protein, designed to allow the body’s own immune system to destroy tumors. Ipilimumab is called an anti-CTLA-4 and is a type of antibody that works to prevent your body’s immune system from stopping to fight your specific cancer. The purpose of this research study is to determine how nivolumab together with ipilimumab, works in treating breast cancer that has spread to other parts of the body. We are also investigating whether there are certain DNA or protein markers in the blood or tumor tissue that may indicate whether the combination will work in future patients.

Treatment: Nivolumab Q2W + Ipilimumab Q6W

Biomarkers: Total mutational burden(TMB) ≥10 mutations/megabase (on tumor sample)

High Level Eligibility Criteria: Measurable metastatic disease; 0-3 lines of prior chemotherapy allowed; No prior anti-PD-1/PD-L1 or CTLA-4 therapy

Phase: II

clinicaltrials.govNCT03789110

Contact: Please contact UT Southwestern via Email or fill out the form below for additional information and eligibility.