PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03362060|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : December 25, 2018
This research study is studying immunotherapy as a possible treatment for metastatic Triple Negative Breast Cancer (TNBC) in participants who are HLA-A2+.
The drugs involved in this study are:
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer Metastatic Breast Cancer||Drug: Pembrolizumab Biological: PVX-410||Phase 1|
This research study is a Phase Ib clinical trial, which tests the safety of an investigational drug combination and also tries to better understand how the investigational intervention affects the body.
"Investigational" means that the FDA (the U.S. Food and Drug Administration) has not approved the combination of PVX-410 and pembrolizumab as a treatment regimen for this specific disease.
The FDA has not approved PVX-410 as a treatment for any disease. PVX-410 is a type of vaccine that may help the immune system stimulate immunity against the cancer cells.
The FDA has not approved pembrolizumab for this specific disease but it has been approved in the United Sates for other types of cancer.
Pembrolizumab is a drug that may treat cancer by working with the immune system. The immune system is the body's natural defense against disease. The immune system sends types of cells throughout the body to detect and fight infections and diseases, including cancer. For some types of cancer, the immune cells do not work as they should and are prevented from attacking the tumors. Pembrolizumab is thought to work by blocking a protein in the cells called Programmed Death-1 (PD-1), which then allows these cells and other parts of the immune system to attack tumors.
In this research study, the investigators are studying the body's immune response to the PVX-410 study vaccine in combination with pembrolizumab. This study will help researchers understand if the vaccine and pembrolizumab can work together to help the body's immune system recognize and treat triple negative breast cancer. The investigators are also studying the safety of the PVX-410 together with the pembrolizumab
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Pembrolizumab in HLA-A2+ Patients With Metastatic Triple Negative Breast Cancer (TNBC)|
|Actual Study Start Date :||December 12, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2024|
Pembrolizumab is a monoclonal antibody checkpoint inhibitor that blocks a protein in T-cells cells called PD-1, which then allows these cells and other parts of the immune system to attack tumors
Other Name: Keytruda
PVX-410 is a type of vaccine composed of 4 9-amino acid peptides that may help the immune system stimulate immunity against cancer cells
- Immune Response following treatment with PVX-410 in combination with pembrolizumab [ Time Frame: 3 years ]The fold activation of T cells from blood of treated patients at week 10 compared to baseline
- Late Immune response after treatment with PVX-410 and pembrolizumab [ Time Frame: 3 years ]The fold activation of T cells from blood of treated patients at week 28 compared to baseline.
- Incidence of treatment emergent adverse events (safety and tolerability) of PVX-410 in combination with pembrolizumab [ Time Frame: 3 years ]Number of patients who develop treatment emergent adverse events according to the Common Toxicity Criteria of Adverse Events (CTCAE) version 4.0
- Progression Free Survival [ Time Frame: 3 years ]The median time from study enrollment to disease progression of all treated participants.
- Overall Survival [ Time Frame: 3 years ]The median time from study enrollment of all participants until death of all treated participants.
- Response rate [ Time Frame: 3 years ]The rate of RECIST defined responses (complete and partial response).
- Disease Control Rate [ Time Frame: 3 years ]The sum of the rates of best response (Complete Response, Partial Response, and Stable Disease).
- Clinical Benefit Rate [ Time Frame: 3 years ]The sum of the RECIST defined rates of Complete Response, Partial Response, and Stable Disease.
- Duration of response [ Time Frame: 3 years ]The median time of the response from time of first response to time of progression for all responding treated participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362060
|Contact: Hannah Parkfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Hannah Park 617-726-8465 email@example.com|
|Principal Investigator: Steven J. Isakoff, MD, PhD|
|Beth Israel Deaconess Medical Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Jaymin Patel, MD 614-667-7216|
|Principal Investigator: Jaymin Patel, MD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Sara Tolaney, MD MPH 617-632-2335|
|Principal Investigator: Sara Tolaney, MD MPH|
|Principal Investigator:||Steven J. Isakoff, MD, PhD||Massachusetts General Hospital|