Dendritic Cell Vaccines Against Her2/Her3, Cytokine Modulation Regimen, and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer

Summary

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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 Evalu...

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. EXPLORATORY OBJECTIVE: I. To evaluate baseline and post-treatment molecular biomarkers (including PD-L1 (via 22C3 assay)) in peripheral tumor tissue and peripheral blood, and correlate with treatment response. OUTLINE: TREATMENT PHASE: Patients receive anti-HER2/HER3 dendritic cell vaccine intradermally (ID) on days 1, 15, and 29. Patients also receive celecoxib orally (PO) twice daily (BID), recombinant interferon alfa-2b IV over 20 minutes, and rintatolimod IV on days 15-17 and 29-31. 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, celecoxib PO BID, recombinant interferon alfa-2b IV over 20 minutes, and rintatolimod IV every 3 months in the opinion of principal investigator.

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