Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

February 22, 2017

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2020

Conditions
Advanced MelanomaTriple-Negative Breast Cancer
Interventions
BIOLOGICAL

Imprime PGG

Imprime PGG is a soluble, β-1,3/1,6 glucan isolated from the cell wall of a proprietary Saccharomyces cerevisiae yeast strain. Imprime PGG acts as a Pathogen-Associated Molecular Pattern (PAMP). Imprime will be administered at a dose of 4 mg/kg IV over a 2-hour infusion time on Days 1, 8 and 15 of each 3-week treatment cycle.

DRUG

Pembrolizumab

Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.

Trial Locations (10)

11794

Stony Brook University Cancer Center, Stony Brook

19107

Thomas Jefferson University Sidney Kimmel Cancer Center, Philadelphia

30318

Piedmont Cancer Institute, Atlanta

30607

University Cancer and Blood Center, Athens

37203

Sarah Cannon Research Institute, Nashville

77090

Millennium Oncology, Houston

80045

University of Colorado Cancer Center, Aurora

80218

Sarah Cannon Research Institute, Denver

85392

Arizona Center for Cancer Care, Avondale

90404

John Wayne Cancer Institute, Santa Monica

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

HiberCell, Inc.

INDUSTRY