Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-01-08 @ 11:00 AM
Study NCT ID:
NCT02826434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2016-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III Triple Negative Breast Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
The names of the study interventions involved in this study are:
* PVX-410 Vaccine
* Durvalumab (MEDI4736)
Detailed Description:
This research study is a Phase Ib clinical trial, which tests the safety of an investigational intervention and also tries to better understand how the investigational intervention affects the body. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved PVX-410 and Durvalumab as a treatment for any disease.
* Durvalumab is a protein that affects your immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls the body's natural immune response, but tumors can interrupt this pathway and partially resist or escape the immune system. By blocking the PD-L1 pathway, Durvalumab may help the immune system identify and catch tumor cells.
* PVX-410 is an investigational vaccine that is being developed to treat multiple myeloma and triple negative breast cancer.
* In this research study, the investigators are studying the body's immune response to the PVX-410 study vaccine in combination with Durvalumab. This study will help researchers understand if the vaccine and Durvalumab can work together to help the body's immune system recognize triple negative breast cancer. The investigators are also studying the safety of the PVX-410 vaccine alone and together with the Durvalumab.
The FDA (the U.S. Food and Drug Administration) has not approved PVX-410 and Durvalumab as a treatment for any disease.
* Durvalumab is a protein that affects your immune system by blocking the PD-L1 pathway. The PD-L1 pathway controls the body's natural immune response, but tumors can interrupt this pathway and partially resist or escape the immune system. By blocking the PD-L1 pathway, Durvalumab may help the immune system identify and catch tumor cells.
* PVX-410 is an investigational vaccine that is being developed to treat multiple myeloma and triple negative breast cancer.
* In this research study, the investigators are studying the body's immune response to the PVX-410 study vaccine in combination with Durvalumab. This study will help researchers understand if the vaccine and Durvalumab can work together to help the body's immune system recognize triple negative breast cancer. The investigators are also studying the safety of the PVX-410 vaccine alone and together with the Durvalumab.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: