- Patients must not have metastatic disease (i.e., must be clinically M0 or Mx
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- systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network [NCCN] and ASCO guidelines)
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- patients must not have locally recurrent disease
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Patients must not have had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs
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- patients must not be planning to receive any of the prohibited therapies during the screening or treatment phases of the study
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Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol
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- however, patients receiving extended adjuvant endocrine therapy for an earlier ER positive breast cancer treated with curative intent and without recurrence for at least 5 years may continue with their endocrine therapy
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- elective surgery or surgery that is not related to cancer therapy is allowed, at the discretion of the treating investigator
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Patients must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis within 2 years prior to registration
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Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
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- replacement therapy (e.g., thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
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