NCT06324240 Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer
| NCT ID | NCT06324240 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Emory University |
| Condition | Anatomic Stage I Breast Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-12-02 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory. Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing.
Eligibility Criteria
Inclusion Criteria: * Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information * Must be age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14 days prior to tissue consent * Absolute neutrophil count \> 1500/mcL (obtained within 14 days prior to vaccine administration) * Absolute lymphocyte count \>= 600 cells/µl (obtained within 14 days prior to vaccine administration) * Platelets \> 100,000 mm (obtained within 14 days prior to vaccine administration) * Hemoglobin \> 9.0 g/dL (obtained within 14 days prior to vaccine administration) (NOTE: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \> 9.0g/dl is acceptable) * Serum creatinine =\< 1.5 x upper limit of normal (ULN) or calculated creatinine clearance \>= 60 mL/min using Cockcroft-Gault equation for patients with creatinine levels \> 1.5 x institutional ULN (obtained within
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