Actively Recruiting
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
70
Participants Needed
30
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.
CONDITIONS
Official Title
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic invasive triple negative breast cancer
- Estrogen and progesterone receptors less than Allred score of 3 or less than 1% positive staining
- HER2 negative by approved testing methods
- PD-L1 negative by approved laboratory assay
- Measurable or evaluable disease
- Willingness to undergo biopsy or have sufficient available tissue for analysis
- No prior treatment for metastatic triple negative breast cancer
- Age 18 years or older
- ECOG performance status of 0 or 1 (Karnofsky score \u2265 60%)
- Body weight over 30 kg
- Life expectancy of at least 12 weeks
- Adequate blood counts and organ function as specified
- Post-menopausal status or negative pregnancy test for women of childbearing potential
- Agreement to use contraception during and after the study as required
- Ability and willingness to comply with study procedures and visits
- HIV-positive patients with controlled infection and stable treatment
- Ability to understand and sign informed consent, or have caregiver consent if impaired
You will not qualify if you...
- Not suitable for carboplatin and gemcitabine as first-line therapy
- Chemotherapy, radiotherapy, or biologic therapy within 30 days prior to study (42 days for certain drugs)
- Prior immunotherapy for metastatic disease
- Unresolved grade 2 or higher side effects from previous cancer treatments, except specified conditions
- Unstable or untreated endocrinological adverse events
- Use of other investigational agents within 30 days
- Recent live attenuated vaccination within 6 months prior or 30 days after starting study drugs
- Major surgery within 28 days prior to first study drug dose, except palliative local surgery
- Use of immunosuppressive medications within 14 days prior except certain steroids
- Spinal cord compression or active brain metastases unless criteria met
- Known allergies to study drugs or vaccine components
- QTcF interval 470 ms or higher
- Uncontrolled illnesses or active infections including tuberculosis, hepatitis B or C
- Pregnant or breastfeeding women
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of pneumonitis, interstitial lung disease, or primary immunodeficiency
- History of other malignancies unless disease-free for at least 1 year
- Likelihood of non-adherence to study schedule
- History of organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Active, Not Recruiting
2
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Active, Not Recruiting
3
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States, 06105
Active, Not Recruiting
5
Yale University
New Haven, Connecticut, United States, 06520
Active, Not Recruiting
6
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
7
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
8
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
9
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
10
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
11
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
12
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States, 33607
Actively Recruiting
13
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States, 33612
Actively Recruiting
14
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
15
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States, 33544
Actively Recruiting
16
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
17
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
18
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
19
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
20
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
21
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
22
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Suspended
23
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
24
Wake Forest University at Clemmons
Clemmons, North Carolina, United States, 27012
Actively Recruiting
25
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
26
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
27
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Active, Not Recruiting
28
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
29
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
Actively Recruiting
30
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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