Carboplatin, Nab-Paclitaxel, and Pembrolizumab in Treating Patients with Metastatic Triple-Negative Breast Cancer

Inclusion Criteria

• Subjects must have histologically or cytologically confirmed metastatic triple negative breast cancer
• Subjects must have received no more than 2 prior therapies for metastatic triple-negative breast cancer
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Hemoglobin >= 10.0 g/dl
• Absolute neutrophil count >= 1,000/uL
• Platelet count >= 100,000/uL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 2.5 x institutional upper limit of normal
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
• Serum creatinine =< 1.5 x normal institutional limits
• Life expectancy of 12 weeks or more
• Subjects must have the ability to understand and the willingness to sign a written informed consent document
• Subjects must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
• Subjects must be willing to undergo a preliminary biopsy of a metastatic focus for research purposes; a second post-treatment biopsy will be offered but will not be mandated

Exclusion Criteria

• Prior treatment toxicities have not resolved to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (except for alopecia and neuropathy)
• Subjects receiving any other investigational agents
• Subjects with radiographically stable treated brain metastases are eligible but must not have been on steroid therapy for at least 4 weeks
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-paclitaxel, carboplatin, pembrolizumab, or other agents used in this study
• Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or breastfeeding women are excluded from this study because the study agents include the potential for teratogenic or abortifacient effects; because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study agents, breastfeeding should be discontinued if the mother is treated with the study agents; these potential risks may also apply to other agents used in this study; female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Patients with conditions requiring immunosuppressive medications or chronic infections (including human immunodeficiency virus [HIV] infection, hepatitis B and C)
• Patients with chronic autoimmune disease
• Patients with prior therapy with antibodies that modulate T-cell function (e.g., anti-PD-1, anti-PD-L1)
• Patients with evidence of active, non-infectious pneumonia
• Patients active infection requiring intravenous systemic therapy
• Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the trial
• Patients who have received a live vaccine within 30 days prior to the first dose of pembrolizumab
• Patients with a known additional malignancy that is progressing or requires active treatment (within the last 5 years); exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy
• Patients who have received monoclonal anti-cancer antibody within 4 weeks of first dose of study drugs
• Patients who have received chemotherapy, small molecule targeted therapy or radiation within the 2 weeks of first dose of study drugs
• Patients who have participated in pembrolizumab (MK-3475) Merck studies
• Patients with carcinomatous meningitis