Clinical Trials Logo

Clinical Trial Summary

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: - PVX-410 - Pembrolizumab - Hiltonol - Montanide


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03362060
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Active, not recruiting
Phase Phase 1
Start date December 12, 2017
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Withdrawn NCT04872608 - A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer Phase 1
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Completed NCT02506556 - Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer Phase 2
Recruiting NCT05534438 - A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer Phase 2
Recruiting NCT03368729 - Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Completed NCT04103853 - Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer Phase 1
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Active, not recruiting NCT03147287 - Palbociclib After CDK and Endocrine Therapy (PACE) Phase 2
Not yet recruiting NCT06062498 - Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer Phase 2
Recruiting NCT05383196 - Onvansertib + Paclitaxel In TNBC Phase 1/Phase 2
Recruiting NCT04095390 - A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer Phase 2
Active, not recruiting NCT04432454 - Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Phase 2
Recruiting NCT03323346 - Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer Phase 2
Recruiting NCT05744375 - Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab Phase 2
Completed NCT02924883 - A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy Phase 2
Completed NCT01942135 - Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) Phase 3
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Active, not recruiting NCT04448886 - Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Phase 2
Completed NCT01401959 - Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy Phase 2
Terminated NCT04720664 - Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer Phase 2