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.
PRIMARY OBJECTIVE: I. Evaluate the clinical response to nab-paclitaxel + durvalumab (MEDI4736) + tremelimumab + neoantigen vaccine (Arm 1) versus (vs.) nab-paclitaxel + durvalumab (MEDI4736) + tremelimumab (Arm 2) in patients with metastatic triple negative breast cancer (TNBC). SECONDARY OBJECTIVE: I. Evaluate the safety of nab-paclitaxel + durvalumab (MEDI4736) + tremelimumab + neoantigen vaccine vs. nab-paclitaxel + durvalumab (MEDI4736) + tremelimumab in patients with metastatic TNBC. EXPLORATORY OBJECTIVES: I. Assess the immune response induced by nab-paclitaxel + durvalumab (MEDI4736) + tremelimumab + neoantigen vaccine vs. nab-paclitaxel + durvalumab (MEDI4736) + tremelimumab in patients with metastatic TNBC. II. Biomarkers of response to therapy will be assessed based on the research biopsies performed at baseline, following the chemotherapy run-in (Part A) and following nab-paclitaxel + durvalumab (MEDI4736) + tremelimumab +/- neoantigen vaccine (Part B). OUTLINE: PART A: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes and carboplatin IV over 30 minutes on days 1 and 8 of each cycle. Treatment repeats every 21 days for up to 18 weeks (6 cycles) in the absence of disease progression or unacceptable toxicity. Patients who experience progression of disease or who are intolerant of treatment may switch and receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 of each remaining cycle or sacituzumab govitecan-hziy IV over 1-3 hours on days 1 and 8 of each remaining cycle. Treatment with nab-paclitaxel repeats every 28 days for up to 2 cycles (for patients with progressive disease) or until a total of 18 weeks of treatment have been completed (for patients who are intolerant of treatment) at the discretion of the treating physician. Treatment with sacituzumab govitecan-hziyl repeats every 21 days for up to 2 cycles (for patients with progressive disease) or until a total of 18 weeks of treatment have been completed (for patients who are intolerant of treatment) at the discretion of the treating physician. PART B: Patients are randomized to 1 of 2 arms. ARM I: Patients receive personalized synthetic long peptide vaccine and poly-ICLC subcutaneously (SC) on days 1, 4, 8, 15, 22, 50, and 78 in the absence of disease progression or unacceptable toxicity. Patients also receive tremelimumab IV over 60 minutes on day 1 of cycles 1-4, durvalumab IV over 60 minutes on day 1 of each cycle and nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive tremelimumab IV over 60 minutes on day 1 of cycles 1-4, durvalumab IV over 60 minutes on day 1 of each cycle and nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, blood and urine sample collection, computed tomography (CT) scan and magnetic resonance imaging (MRI) on study. After completion of study treatment, patients are followed up every 3 months for 1 year, then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
86
Undergo tumor biopsy
Undergo blood and urine sample collection
Given IV
Undergo CT scan
Given IV
Given IV
Undergo MRI
Given IV
Given SC
Given SC
Given IV
Given IV
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
ACTIVE_NOT_RECRUITINGUniversity of California Davis Comprehensive Cancer Center
Sacramento, California, United States
TERMINATEDUCHealth University of Colorado Hospital
Aurora, Colorado, United States
RECRUITINGSmilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Progression-free survival (PFS)
The median PFS in each arm and their 80% confidence intervals will be assessed using Kaplan-Meier product limit methods and compared by log-rank test.
Time frame: From initiation of Part B to progression or death, assessed at 6 and 12 months
Incidence of adverse events
Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. The number and percentage of subjects experiencing each type of adverse event will be tabulated by severity, and relationship to treatment. If appropriate, confidence intervals will be used to characterize the precision of the estimate.
Time frame: Up to day 22
Clinical response rate
Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be assessed and their 95% confidence intervals will be calculated.
Time frame: Up to 52 weeks
Clinical benefit rate (complete response, partial response, stable disease)
Will be assessed by RECIST 1.1. Will be assessed and their 95% confidence intervals will be calculated.
Time frame: Up to 52 weeks
Overall survival (OS)
The median OS and 95% confidence interval will also be assessed using Kaplan-Meier product limit methods and compared by log-rank test.
Time frame: Up to 52 weeks
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Yale University
New Haven, Connecticut, United States
ACTIVE_NOT_RECRUITINGUM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
RECRUITINGUM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
RECRUITINGUM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
RECRUITINGUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
RECRUITINGUM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
RECRUITING...and 20 more locations