Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
NCT04348747 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2026-05-11
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.
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
- BIOLOGICAL
-
Anti-HER2/HER3 Dendritic Cell Vaccine
Given ID
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
Roswell Park Cancer Institute
lead OTHER
Principal Investigators
-
Sheheryar Kabraji, BMBCh · Roswell Park Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-19
- Primary Completion
- 2027-06-15
- Completion
- 2027-12-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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