NCT04348747

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

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Metastatic Malignant Neoplasm in the Brain
• Metastatic Triple-Negative Breast Carcinoma
• Prognostic Stage IV Breast Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Anti-HER2/HER3 Dendritic Cell Vaccine	Given ID
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2022-12-19
• Primary completion: 2027-06-15
• Completion: 2027-12-15
• First posted: 2020-04-16
• Last updated: 2026-02-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study