Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Emory University
You may qualify if…
- ✓ 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 14 days prior to vaccine administration)
You may not qualify if…
- ✕ Weight of the tumor tissue is less 1 gram
- ✕ Clinically significant comorbid conditions such as cardiovascular disease or significant peripheral vascular (e.g., uncontrolled hypertension, myocardial infarction, unstable angina) within 6 months of study entry, serious cardiac arrhythmia requiring medication, and uncontrolled infection
- ✕ No second malignancy except prior breast cancer or except non-melanomatous skin cancer within the past 5 years
- ✕ Ongoing or planned systemic anti-cancer therapy or radiation therapy. Last cycle of cytotoxic therapy must be \>= 21 days prior to C1D1 of vaccine. Last cycle of checkpoint inhibitor therapy be \>= 28 days prior to C1D1 of vaccine. Last dose of radiotherapy must be \>= 14 days prior to C1D1 of vaccine
- ✕ Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment
- ✕ Has a known history of active tuberculosis (Bacillus Tuberculosis)
- ✕ History of allogeneic organ transplant
- ✕ Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for management of brain metastases for at least 7 days prior to study treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
Where it's recruiting
Atlanta
Source: ClinicalTrials.gov · NCT06324240 · last updated 2026-01-26