Adjuvant PVX-410 Vaccine and Durvalumab in Stage II/III 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: NCT02826434|
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : December 25, 2018
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)
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: PVX-410 Biological: Durvalumab Drug: Hiltonol||Phase 1|
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.
|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 Durvalumab in Human Leukocyte Antigen (HLA)-A2+ Subjects Following Standard Treatment of Stage II or III Triple Negative Breast Cancer|
|Actual Study Start Date :||August 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2022|
Experimental: PVX-410 and Durvalumab
Each patient will receive 6 PVX-410 vaccine injections and 2 infusions of Durvalumab.
This is a Vaccine that will be injected intramuscularly as a mixture with an adjuvant.
This is an intravenous infusion of a monoclonal antibody.
Other Name: MEDI4736
This is an intramuscular injection of an adjuvant to enhance the immune response to vaccine.
Other Name: poly-ICLC
- Dose Limiting Toxicity Rate of PVX-410 in Combination With Durvalumab [ Time Frame: 4 Weeks ]To assess the safety of the vaccine and PDL1 inhibitor.
- Immune Response Rate of cluster designation 8 (CD8)+ Cytotoxic T Lymphocytes (CTLs) to Vaccine-Specific Peptides [ Time Frame: 14 weeks from first dose ]To assess the response of the immune system after treatment with the vaccine and PDL1 inhibitor.
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): NCT02826434
|Contact: Steven Isakoff, MD, PhD||617-726-6500||SISAKOFF@mgh.harvard.edu|
|Contact: Rachel M Deeringfirstname.lastname@example.org|
|United States, Florida|
|Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33607|
|Contact: Hatem Soliman, MD 813-745-8410 Hatem.email@example.com|
|Principal Investigator: Hatem Soliman, MD|
|United States, Massachusetts|
|Massachusetts general Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Steven Isakoff, MD, PhD 617-726-6500 SISAKOFF@mgh.harvard.edu|
|Principal Investigator: Steven Isakoff, MD, PhD|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Nadine Tung, MD 617-667-1962 firstname.lastname@example.org|
|Principal Investigator: Nadine Tung, MD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Sara Tolaney, MD 617-632-2335 email@example.com|
|Principal Investigator: Sara Tolaney, MD|
|United States, New York|
|New York University School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Sylvia Adams, MD 212-731-5795 Sylvia.firstname.lastname@example.org|
|Principal Investigator: Sylvia Adams|
|Principal Investigator:||Steven Isakoff, MD, PhD||Massachusetts General Hospital|