MedTrace Logo

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

NCT03246685 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-12-14

No results posted yet for this study

Summary

Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination Hypothesis: Restore (for subjects who have failed pembrolizumab mono therapy) or enhance (for subjects who actively experiencing SD) sensitivity to checkpoint inhibitors (CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune systems by combining Imprime PGG with pembrolizumab.

The study will require documenting at least 5 objective responses among the 38 subjects enrolled who have failed prior pembrolizumab monotherapy and at least 17 objective responses among the 49 subjects enrolled who are actively experiencing stable disease following at least 4 cycles (but no more than 8 cycles) of pembrolizumab monotherapy.

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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-08
Primary Completion
2018-04-13
Completion
2018-04-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246685 on ClinicalTrials.gov