Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast 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 since the first dose of anti-HER2/3 vaccine.
* VII. Rate of failure of irradiated lesions.

OUTLINE:

TREATMENT PHASE: Patients receive anti-HER2/HER3 dendritic cell vaccine intradermally (ID) on days 1, 22, and 43. Patients also receive Pembrolizumab intravenous (IV) infusion on the same day.

MAINTENANCE PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients may also receive a booster dose of anti-HER2/HER3 dendritic cell vaccine ID, every 3-6 months in the opinion of principal investigator.