Actively Recruiting
Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer
Led by Emory University · Updated on 2026-01-26
18
Participants Needed
4
Research Sites
56 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization
- Age 18 years or older
- ECOG performance status of 0 or 1 within 14 days before tissue consent
- Absolute neutrophil count greater than 1500/mcL within 14 days before vaccine
- Absolute lymphocyte count at least 600 cells/μl within 14 days before vaccine
- Platelets greater than 100,000/mm within 14 days before vaccine
- Hemoglobin greater than 9.0 g/dL within 14 days before vaccine
- Serum creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance at least 60 mL/min within 14 days before vaccine
- Total bilirubin less than or equal to 1.5 times upper limit of normal or direct bilirubin less than or equal to 1 times upper limit of normal within 14 days before vaccine
- AST and ALT less than or equal to 2.5 times upper limit of normal (or 5 times if liver metastases present) within 14 days before vaccine
- Bilirubin less than or equal to 1.5 times upper limit of normal (or less than or equal to 3.0 mg/dL with Gilbert's disease) within 14 days before vaccine
- INR or PT less than or equal to 1.5 times upper limit of normal unless on anticoagulant therapy within therapeutic range within 14 days before vaccine
- aPTT less than or equal to 1.5 times upper limit of normal unless on anticoagulant therapy within therapeutic range within 14 days before vaccine
- Triple negative breast cancer defined by ER/PR less than or equal to 10% and HER2 negative
- Metastatic or inoperable locally advanced disease defined by biopsy or clinical evidence
- Have received less than or equal to 3 lines of chemotherapy for metastatic/advanced disease
- Prior checkpoint inhibitor permitted; PD-L1 positive patients must have had pembrolizumab
- Early stage TNBC (clinical or pathologic Stage I-III) eligible for Phase 1a or 1b
- Completed adjuvant radiotherapy at least 14 days before vaccine
- Completed capecitabine at least 28 days before vaccine or enrolled before capecitabine but delayed start
- Completed olaparib at least 28 days before vaccine or enrolled before olaparib but delayed start
- Vaccine injections at least 28 days after final chemotherapy cycle for upfront surgery patients
- Residual disease after neoadjuvant therapy following KEYNOTE 522 regimen or other chemotherapy with specific vaccine start timelines
- Tumor tissue weight at least 1 gram for vaccine production
- Measurable disease not required but sufficient tumor for vaccine
- Germline BRCA1/BRCA2 testing done or planned
- Able and willing to complete study as scheduled
- Signed informed consent
You will not qualify if you...
- Tumor tissue weight less than 1 gram
- Significant comorbid conditions such as recent cardiovascular disease or uncontrolled infection
- Any second malignancy except prior breast cancer or non-melanoma skin cancer within 5 years
- Ongoing or planned systemic anti-cancer or radiation therapy within required washout periods
- Pregnant, breastfeeding, or planning to conceive/father children during study and up to 120 days after last treatment
- History of active tuberculosis
- History of organ transplant
- Active central nervous system metastases or carcinomatous meningitis
- Immunodeficiency or recent systemic immunosuppressive therapy except low-dose corticosteroids
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of non-infectious pneumonitis requiring steroids or active pneumonitis
- Failure to recover from severe toxicity from prior treatment
- Prior grade 4 immune-related adverse events from checkpoint inhibitors; grade 2 or 3 allowed if resolved to grade 1 or less
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Grady Health System
Atlanta, Georgia, United States, 30303
Actively Recruiting
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
3
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
Research Team
K
Keerthi Gogineni, MD, MSHP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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