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ACTIVE NOT RECRUITING
NCT02826434
PHASE1

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

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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)

Official title: A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Durvalumab in Human Leukocyte Antigen (HLA)-A2+ Subjects Following Standard Treatment of Stage II or III Triple Negative Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2016-08-18

Completion Date

2027-09

Last Updated

2025-10-01

Healthy Volunteers

No

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.

Locations (5)

Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Massachusetts general Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

New York University School of Medicine

New York, New York, United States