Study of Neoadjuvant Imprime PGG and Pembrolizumab for Stage III, Resectable Melanoma

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

August 15, 2021

Primary Completion Date

February 18, 2023

Study Completion Date

May 18, 2023

Conditions
Pathologic Stage III Cutaneous Melanoma AJCC v8
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.

BIOLOGICAL

Pembrolizumab

Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 (PD-1) protein. Pembrolizumab will be administered at 200 mg IV Q3W for 9 weeks.

Trial Locations (4)

10029

Ichan School of Medicine at Mount Sinai, New York

15212

Allegheny Health Network, Pittsburgh

90603

Innovative Clinical Research Institute, Whittier

92093-0990

UC San Diego Moores Cancer Center, La Jolla

Sponsors

Lead Sponsor

All Listed Sponsors
lead

HiberCell, Inc.

INDUSTRY

NCT04995094 - Study of Neoadjuvant Imprime PGG and Pembrolizumab for Stage III, Resectable Melanoma | Biotech Hunter | Biotech Hunter