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Drug Combination Study for Patients with Metastatic Breast Cancer

Clinical Trial Title: 
A multicenter, open-label, phase 2 study of imprime PGG and pembrolizumab in subjects with advanced melanoma failing front-line treatment with checkpoint inhibitors or triple negative breast cancer failing front-line chemotherapy for metastatic disease.
Clinical Trial Protocol ID: 
16122205
Clinical Trial Investigator Name: 
Ruta D. Rao, MD
Clinical Trial Protocol Description: 

The main purpose of this study is to find out the effects of investigational drug, Imprime PGG, when given together with pembrolizumab, which is also known as Keytruda®. Imprime PGG when given with pembrolizumab may help the immune system to fight triple-negative breast cancer (TNBC). Pembrolizumab is approved by the FDA when given alone for the treatment of advanced metastatic melanoma, but not for TNBC. The combination of these drugs used in this study is investigational. This is a multicenter study that will be conducted worldwide.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have a diagnosis of metastatic (Stage IV) breast cancer.
  • Have progressive disease (PD) after at least 1 line of chemotherapy.
  • Are willing to consider providing tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality, for assessment of biomarker status.

You will be excluded from the study if any of the following criteria apply to you:

  • Have breast cancer that is suitable for local therapy administered with curative intent.
  • Are currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Have received prior therapy with an anti-PD-1, anti-PD-L1, anti-CTLA-4, or anti-PD-L2 agent.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Breast Cancer
Contact Phone: 
(312) 942-2993
Contact Name: 
Chelsea McPeek, RN