SGT-53, Carboplatin, and Pembrolizumab for the Treatment of Metastatic Triple Negative Inflammatory Breast Cancer

Exclusion Criteria

• •* Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
• •* Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been \>= 14 days after the last dose of the previous investigational agent
• •* Immune related neurologic disease
• •* Multiple sclerosis
• •* Autoimmune (demyelinating) neuropathy
• •* Guillain-Barre syndrome
• •* Myasthenia gravis
• •* Systemic autoimmune disease such as systemic lupus erythematosus (SLE)
• •* Connective tissue diseases
• •* Scleroderma
• •* Inflammatory bowel disease (IBD)
• •* Crohn's
• •* Ulcerative colitis
• •* Patients with a history of toxic epidermal necrolysis (TEN)
• •* Stevens-Johnson syndrome
• •* Anti-phospholipid syndrome
• •* NOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
• •Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days prior to first dose of study drug
• •* NOTE: Inhaled steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted
• •* Hypertension that is not controlled on medication
• •* Ongoing or active infection requiring systemic treatment
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia
• •* Psychiatric illness/social situations that would limit compliance with study requirements
• •* Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
• •* NOTE: in the event that 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to start receiving study medication
• •Patients who have a known additional malignancy that is progressing or has required active treatment within the past 2 years
• •* NOTE: The following prior malignancies are allowed on study: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years
• •Patients with a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection
• •* NOTE: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority
• •Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
• •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
• •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• •Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 130 days after the last dose of trial treatment
• •* NOTE: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed