Clinical Trial Open for STEMVAC for Metastatic Triple-Negative Breast Cancer
Breast cancer is one of the most common cancers and the second leading cause of cancer-related death among women. While advances in targeted therapies have improved patient outcomes for several breast cancer subtypes, metastatic triple-negative breast cancer (TNBC) remains one of the most challenging forms of the disease to treat. Although immune checkpoint inhibitors (ICIs) combined with chemotherapy have improved survival for some patients with metastatic TNBC, this benefit is limited to patients whose tumors express PD-L1. Treatment options for patients with PD-L1-negative tumors remain limited.
The Cancer Vaccine Institute (CVI) is responding to this challenge and is now enrolling participants for a Phase II clinical trial evaluating STEMVAC, an investigational cancer vaccine, in combination with chemotherapy for participants with PD-L1-negative metastatic TNBC. This study is generously funded by the Kuni Foundation and led by Dr. Brie Chun, CVI Principal Investigator and breast oncologist.
“With the way side effects can build up for patients and for how cancers can become resistant to chemotherapy, we urgently need new strategies to treat these cancers,” Dr. Chun says.
The Phase II study builds on previously published preclinical research suggesting that vaccination may enhance the effectiveness of chemotherapy.
“Dr. Denise Cecil showed that vaccine-generated immune responses synergized with chemotherapy - the mice that were treated with a vaccine and chemotherapy had more reduction in tumor volume than mice that had either treatment alone,” Dr. Chun recalls. “This will open a new opportunity for immunotherapies in metastatic TNBC.”
STEMVAC is designed to train the immune system to recognize and target five proteins that are expressed on breast cancer stem cells. These proteins are involved in biological pathways associated with tumor initiation and growth, disease recurrence, and drug resistance. Chemotherapy works by killing cancer cells or preventing them from growing and dividing. By combining STEMVAC with chemotherapy, researchers hope to enhance the immune system’s ability to recognize and attack cancer cells while improving the effectiveness of chemotherapy. This Phase II study will evaluate whether this combination is safe and can improve outcomes for patients with PD-L1-negative metastatic TNBC.
Patients diagnosed with PD-L1-negative metastatic TNBC who are receiving chemotherapy as first- or second-line treatment may be eligible to participate in this clinical trial. Participants would receive the STEMVAC vaccine with their oncologist-selected chemotherapy regimen. After three initial STEMVAC doses, participants will receive booster vaccines until disease progression.
For more information on eligibility criteria and learn more about this clinical trial, visit here.
