MedTrace Logo

Pembrolizumab + Imprime PGG for Metastatic Non-small Cell Lung Cancer After Progression on First-Line Therapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017

NCT03003468 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-01-20

Study results available
· View outcomes & findings →

Summary

This is an open label, multi-institutional, single arm study with a dose escalation phase Ib cohort, followed by a phase II cohort of pembrolizumab and Imprime PGG. No randomization or blinding is involved.

Conditions

Interventions

DRUG

Imprime PGG

Arm A: Phase Ib Cohort 1: 2mg/kg IV; Arm A: Phase Ib Cohort 2: 4mg/kg IV

DRUG

MK-3475

200mg IV

DRUG

Imprime PGG

Arm B: Phase II treatment: administered at the maximum safe dose of 2mg or 4 mg as established in the Phase Ib cohort study.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • HiberCell, Inc.

    collaborator INDUSTRY

  • Lawrence Feldman, MD

    lead OTHER

Principal Investigators

  • Lawrence Feldman, M.D. · Big Ten Cancer Research Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2021-11-22
Completion
2022-11-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT03003468 on ClinicalTrials.gov