Establishing the Recommended Biological Dose for AE37 Peptide Vaccine in Combination With Pembrolizumab That Will Enhance the Tumor-specific Immune Response and Demonstrate Efficacy in Patients With Advanced Triple-negative Breast Cancer

PHASE2UnknownINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

May 3, 2019

Primary Completion Date

June 30, 2023

Study Completion Date

June 30, 2024

Conditions
Triple-negative Breast Cancer
Interventions
BIOLOGICAL

AE37 Peptide vaccine

"Starting dose: AE37 vaccine 1000 micrograms split into 2 doses given as intradermal injection on day 1 of every 3 week cycle (21 day cycle) for 5 cycles.~Should ≥ grade 3 systemic toxicities (DLT) occur in \> 25% (4) of the first 13 patients (4 or more) the study therapy vaccine dose will be de-escalated to 500 micrograms (dose level -1)."

BIOLOGICAL

Pembrolizumab

Pembrolizumab 200 mg IV on day 1 of every 3 week cycle (21 day cycle) for 2 years (35 cycles)

Trial Locations (6)

26506

West Virginia University, Morgantown

43212

Stefanie Spielman Comprehensive Cancer Center, Columbus

44195

Cleveland Clinic, Cleveland

62226

Cancer Care Specialists of Central Illinois-Swansea, Swansea

62401

Crossroads Cancer Center, Effingham

62526

Cancer Care Specialists of Central Illinois, Decatur

Sponsors
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

NSABP Foundation Inc

NETWORK

lead

NuGenerex Immuno-Oncology

INDUSTRY