A Phase IIa Study of Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) or Hormone Receptor Positive (HR+) Breast Cancer.
Roswell Park Cancer Institute
Summary
This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer or HER+ Breast cancer that has spread to the brain (brain metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. . Pembrolizumab is an "immune checkpoint inhibitor" which is designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules" or by activating stimulatory molecules. Giving dendritic cell vaccines and pembrolizumab may shrink the cancer.
Description
PRIMARY OBJECTIVE: * I. The best overall central nervous system (CNS) response as per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM). SECONDARY OBJECTIVES: * I. Volumetric quantification of brain metastases. * II. The non-CNS (i.e. of systemic disease) response rate as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * III. The median CNS, non-CNS and overall progression free survival (PFS). * IV. The median overall survival (OS). * V. The safety of this regimen. * VI. The proportion of patients not requiring retreatment for their brain metastasis at 6 months…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * female participant is eligible to participate if she is not pregnant,not breastfeeding, and at least one of the following conditions applies: * Not a woman of childbearing potential (WOCBP) * A WOCBP who agrees to follow contraceptive guidance * WOCBP must agree to use acceptable birth control methods for the duration of the study and until persistence of the study drug is no longer detected in the peripheral blood:this may be a period of several years. Methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine dev…
Interventions
- BiologicalAnti-HER2/HER3 Dendritic Cell Vaccine
Given ID
- BiologicalPembrolizumab
Given IV
Locations (3)
- Moffitt Cancer CenterTampa, Florida
- Roswell Park Cancer InstituteBuffalo, New York
- University of Virginia Comprehensive Cancer CenterCharlottesville, Virginia