Breast Cancer

A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread

Study Overview

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of nivolumab in combination with chemotherapy drug nab-paclitaxel and/or another immunotherapy drugs including, but not limited to, ipilimumab in participants with breast cancer. This clinical trial is targeting multiple mechanisms involved in generating and maintaining antitumor immune response will lead to a tolerable and robust anti-tumor response. This study utilizes an innovative clinical trial design to determine the safety, tolerability, pharmacodynamic activity and efficacy of targeting multiple, distinct combination regimens that modulate several immune and non-immune mechanisms by escalating the number of therapies administered.

Study Details

OPDIVO® (nivolumab) and Yervoy™ (ipilimumab) are types of antibodies (a type of human protein) used in what’s called immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab is approved for treatment of the several indications by multiple regulatory bodies, including by the US Food and Drug Administration (FDA) and by the European Medicines Agency (EMA). In September 2017 nivolumab received approval by the US FDA for treatment of patients with previously treated liver cancer. In August 2018 nivolumab received approval by the US FDA for treatment of patients with previously treated metastatic small cell lung cancer.  Ipilimumab is approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other health authorities for the treatment of melanoma and advanced kidney cancer.   Nab-paclitaxel is a chemotherapy drug approved by the US Food and Drug Administration (FDA) for the treatment of metastatic breast cancer, advanced non-small cell lung cancer, and metastatic pancreatic cancer.

This study involves research and is conducted to determine the safety, tolerability and effectiveness of a study drug called if nivolumab (also known as OPDIVO™ or BMS-936558) in combination with nab-paclitaxel (also known as Abraxane), ipilimumab (also known as Yervoy™ or BMS-734016), and other immunotherapies in participants with hormone receptor positive breast cancer. 

Treatment: Nivolumab (also known as OPDIVO™ or BMS-936558) in combination with nab-paclitaxel (also known as Abraxane), ipilimumab (also known as Yervoy™ or BMS-734016), and other immunotherapies in participants with hormone receptor positive breast cancer. 

Inclusion Criteria:

  • Histological and cytological confirmation of adenocarcinoma of the breast
  • Documented HER2 negative and estrogen receptor (ER) positive status of primary or metastatic tumor tissue using the most recently assessed tumor specimen, according to the local laboratory parameters
  • ER negativity is defined as < 1% of tumor cells expressing hormonal receptors via IHC analysis
  • At least one measurable lesion, as per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT) or magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Women and Men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

  • Allergy or hypersensitivity to any study drugs or their excipients
  • Any other sound medical, psychiatric and/or social reason as determined by the investigator
  • Active, known, or suspected autoimmune disease or immune-related diseases
  • History of unstable or deteriorating cardiac disease within the previous 12 months prior to screening
  • Prior therapy with anti-programmed death 1 (PD-1), anti-programmed death-ligand 1 (PD-L1) or anti-Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) class antibody
  • Any major surgery within 4 weeks of the first dose of study treatment

Phase: I

clinicaltrials.gov: NCT04132817

Contact: Please contact UT Southwestern via Email (breastcancerclinicaltrials@utsouthwestern.edu)