Phase 2 Study of Imprime PGG & Pembrolizumab in Subjects With Adv SCCHN Who Failed Pembro Monotherapy or Experiencing SD

PHASE2TerminatedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

November 8, 2017

Primary Completion Date

April 13, 2018

Study Completion Date

April 13, 2018

Conditions
Squamous Cell Carcinoma of the Head and Neck
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 (1)

98405

Northwestern Medical Specialties, PLLC, Tacoma

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

HiberCell, Inc.

INDUSTRY