Phase II Study of STEMVAC Cancer Vaccine Combined With Chemotherapy in Adults With PD-L1 Negative Metastatic Triple-Negative Breast Cancer

What this Trial Is About

This research evaluates how well a cancer vaccine called STEMVAC works alongside chemotherapy in treating patients with PD-L1 negative, triple-negative breast cancer that has spread to other parts of the body. STEMVAC targets proteins found on breast cancer stem cells and aims to boost the immune system to attack tumor cells. This phase II trial focuses on patients with metastatic triple-negative breast cancer who have not received prior cancer immunotherapy in this setting. Participants receive standard-of-care chemotherapy as decided by their oncologist. They also get three initial doses of STEMVAC combined with sargramostim injected into the skin every 21 to 28 days, timed around their chemotherapy treatments. Following the initial doses, two booster doses of STEMVAC with sargramostim are given at four and seven months, and then every six months if there is no disease progression or unacceptable side effects. Image-guided biopsies, CT or PET scans, and blood samples are collected during the study, including possibly during screening. During the study, participants undergo regular scans and biopsies for research purposes while receiving treatment. After completing the study treatment, they have a follow-up visit at 21 or 28 days and then visits every six months for up to three years to monitor their health and cancer status. Researchers assess immune responses to the vaccine, treatment safety, overall response rates, progression-free survival, and overall survival throughout the study period.

A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer