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Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer

NCT02826434 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-10-01

No results posted yet for this study

Summary

The purpose of this research study is to evaluate Immunotherapy with a peptide vaccine and Programmed Death Ligand 1 (PD-L1) inhibitor as a possible adjuvant treatment for Stage II or III Triple Negative Breast Cancer. This research study is studying the safety, tolerability, and immune response of these treatments.

The names of the study interventions involved in this study are:

* PVX-410 Vaccine
* Durvalumab (MEDI4736)

Conditions

Interventions

BIOLOGICAL

PVX-410

This is a Vaccine that will be injected intramuscularly as a mixture with an adjuvant.

BIOLOGICAL

Durvalumab

This is an intravenous infusion of a monoclonal antibody.

DRUG

Hiltonol

This is an intramuscular injection of an adjuvant to enhance the immune response to vaccine.

Sponsors & Collaborators

  • OncoPep, Inc.

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Steven Isakoff, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-18
Primary Completion
2026-12-31
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02826434 on ClinicalTrials.gov