Clinical trialNCT04024800UnknownPhase 2Interventional

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

SponsorNuGenerex Immuno-OncologyEnrollment29Triple-negative Breast Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study will look to establish the recommended biologic dose of AE37 in combination with pembrolizumab that will enhance the tumor-specific immune response and demonstrate efficacy in patients with advanced triple-negative breast cancer. This study will take place in two parts. Stage 1 will be the safety cohort (13 patients) to determine the recommended dose of AE37 vaccine that can safely be administered with pembrolizumab. Stage 2 will be an expansion cohort (16 patients) that will consist of the recommended dose of AE37 determined in Stage 1.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Norman Wolmark, MD
NSABP Foundation Inc
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Cancer Care Specialists of Central Illinois
Decatur, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Cancer Care Specialists of Central Illinois-Swansea
Swansea, Illinois, United States
Cleveland Clinic
Cleveland, Ohio, United States
Stefanie Spielman Comprehensive Cancer Center
Columbus, Ohio, United States
West Virginia University
Morgantown, West Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AE37 Peptide vaccinePembrolizumab →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 3 May 2019
Primary completion: 30 Jun 2023
Completion: 30 Jun 2024
Last update posted: 2 Jun 2021
Registered enrollment: 29
Registry id: NCT04024800

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.