Carboplatin with or without Nivolumab in Treating Patients with Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

Inclusion Criteria

• Participants must have histologically or cytologically confirmed invasive breast cancer, with unresectable locally advanced or metastatic disease; participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation
• Estrogen-receptor and progesterone-receptor expression both =< 1% by immunohistochemistry (IHC), and HER2-negative status as determined by the current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines; if a patient has more than one histological result, the most recent sample will be considered for inclusion
• Participants must have PD-L1 status available at the time of registration; standard local testing with any PD-L1 antibody that has been validated in a Clinical Laboratory Improvement Act (CLIA)-certified environment will be acceptable for including patients on trial; primary or metastatic samples may be tested for PD-L1 status
• Participants must have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline; previously collected archival tissue will also be obtained on all participants; for participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) the archival tissue alone will be acceptable; tissue needs to be located and availability confirmed at time of registration; participants must agree to a mandatory repeat biopsy 3-6 weeks after starting treatment, if tumor is safely accessible; for patients randomized to carboplatin alone who decide to crossover to nivolumab + nab-paclitaxel at time of progression, a mandatory biopsy will be required, if tumor is safely accessible, prior to initiating crossover treatment; participants must also agree to undergo this biopsy, if applicable
• Participants must have received 0 prior chemotherapeutic regimens for metastatic breast cancer; prior platinum in the neo/adjuvant setting is permissible, if at least 6 months elapsed since the end of adjuvant systemic therapy to the development of metastatic disease; all toxicities related to prior chemotherapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 grade 1 or lower
• Prior poly-adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitors are not allowed in the metastatic setting; prior PARP inhibitors in the neo/adjuvant setting are permissible, if at least 6 months elapsed since the end of adjuvant systemic therapy to the development of metastatic disease; all toxicities related to prior biologic therapy must have resolved to CTCAE v4.0 grade 1 or lower
• Patients may have received prior radiation therapy; radiation therapy must be completed at least 7 days prior to registration, and all toxicities related to prior radiation therapy must have resolved to CTCAE v4.0 grade 1 or lower; patients may not have had > 25% of their bone marrow radiated
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky > 60%)
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Hemoglobin >= 9.0 g/dl
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (or =< 2.0 x ULN in patients with documented Gilbert's syndrome)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional ULN or =< 5 x institutional ULN for participants with documented liver metastases
• Serum creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 45 mL/min/ 1.73 m^2 for participants with creatinine levels above institutional ULN
• Note: supportive care (e.g. transfusion of red blood cells) is allowed to meet eligibility criteria
• Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to registration * Childbearing potential is defined as: participants who have not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus)
• Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception; contraception is required starting with the first dose of study medication through 150 days (5 months) after the last dose of study medication; examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established and proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception
• Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab and 7 months after the last dose of study treatment (i.e., 90 days [duration of sperm turnover] plus the time required for the investigational drug to undergo approximately five half-lives)
• Participants on bisphosphonates or receptor activator of nuclear factor kappa B (RANK) ligand inhibitors may continue receiving therapy during study treatment
• The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document

Exclusion Criteria

• Concurrent administration of any other anti-cancer therapy during the course of this study (bisphosphonates and RANK ligand inhibitors are allowed)
• Prior hypersensitivity to platinum chemotherapy or to any of the excipients of platinum or nivolumab therapy
• Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including pembrolizumab, ipilimumab, and any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
• Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms; participants with a history of treated central nervous system (CNS) metastases are eligible; treated brain metastases are defined as those without ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or computed tomography [CT] scan) completed during screening; any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for >= 7 days prior to registration; treatment for brain metastases may include whole brain radiotherapy, radiosurgery, surgery or a combination as deemed appropriate by the treating physician; radiation therapy must be completed at least 7 days prior to registration
• Major surgery within 2 weeks prior to registration; patients must have recovered from any effects of any major surgery
• Uncontrolled, significant intercurrent or recent illness including, but not limited to, ongoing or active infection, uncontrolled non-malignant systemic disease, uncontrolled seizures, or psychiatric illness/social situation that would limit compliance with study requirements in the opinion of the treating investigator
• Participant has a medical condition that requires chronic systemic steroid therapy (> 10 mg of prednisone daily or equivalent) or any other form of immunosuppressive medication (including disease modifying agents) and has required such therapy in the last 2 years; replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy
• Participant has documented history of autoimmune disease or syndrome that currently requires systemic steroids or immunosuppressive agents
• History or evidence of active, non-infectious pneumonitis or interstitial lung disease
• Individuals with a history of a second malignancy are ineligible except for the following circumstances; individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy; individuals with the following cancers that have been diagnosed and treated within the past 3 years are eligible: cervical/prostate carcinoma in situ, superficial bladder cancer, non-melanoma cancer of the skin; patients with other cancers diagnosed within the past 3 years and felt to be at low risk of recurrence should be discussed with the study sponsor to determine eligibility
• Participant is known to be positive for the human immunodeficiency virus (HIV), hepatitis B surface antigen (HepBsAg), or hepatitis C virus (HCV) RNA; HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions of combination antiretroviral therapy with study drugs; in addition, these participants are at increased risk of fatal infections when treated with marrow-suppressive therapy
• The participant has received a live vaccine within 28 days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine; the use of the inactivated seasonal influenza vaccine is allowed
• Women who are pregnant or breastfeeding or adults of reproductive potential not employing an adequate method of contraception * Childbearing potential is defined as: participants who have not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause) and have not undergone surgical sterilization (removal of ovaries and/or uterus)