29
Participants
Start Date
May 3, 2019
Primary Completion Date
June 30, 2023
Study Completion Date
June 30, 2024
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)."
Pembrolizumab
Pembrolizumab 200 mg IV on day 1 of every 3 week cycle (21 day cycle) for 2 years (35 cycles)
West Virginia University, Morgantown
Stefanie Spielman Comprehensive Cancer Center, Columbus
Cleveland Clinic, Cleveland
Cancer Care Specialists of Central Illinois-Swansea, Swansea
Crossroads Cancer Center, Effingham
Cancer Care Specialists of Central Illinois, Decatur
Lead Sponsor
Merck Sharp & Dohme LLC
INDUSTRY
NSABP Foundation Inc
NETWORK
NuGenerex Immuno-Oncology
INDUSTRY