Nivolumab and Cyclophosphamide in Treating Patients with Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome

Inclusion Criteria

• Meets one of the following disease criteria: * Primary (de novo) AML or higher-risk MDS with induction failure: No complete remission (CR) after 2 or more induction attempts with high dose chemotherapy or hypomethylating agents +/- other agents. Higher risk MDS defined as risk score > 4.5 based on the revised International Prognostic Scoring System (IPSS) criteria * Secondary AML (from antecedent hematologic malignancy or treatment-related): Not in CR after 1 or more cycles of chemotherapy * Relapsed AML: Blast count >= 5% in bone marrow or peripheral blood after prior attainment of CR; relapse at any time but >= 100 days following allogeneic hematopoietic cell transplantation (HCT) * Relapsed MDS: Morphologic evidence of relapse or increase in blasts >= 5% in bone marrow or peripheral blood after prior hematologic improvement; or partial or complete response; relapse at any time but >= 100 days following allogeneic HCT
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Absolute lymphocyte count: >= 500 cells/mm^3 (within 14 days of study registration)
• Total bilirubin =< 3 x upper limit of institutional normal (ULN) (within 14 days of study registration)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 5 x ULN (within 14 days of study registration)
• Serum creatinine =< 2 mg/dL (within 14 days of study registration)
• No oxygen requirement on room air or requiring =< 2L supplemental oxygen (O2) (within 14 days of study registration)
• Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and continuing (23 weeks for females, 31 weeks for males) after the last dose of nivolumab
• Voluntary written consent

Exclusion Criteria

• Pregnant or breastfeeding - The agents used in this study fall under Pregnancy Category D - Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days of study drug administration
• Prior allogeneic hematopoietic stem cell transplantation within previous 100 days (note patients with a prior allogeneic (allo)HSCT receive nivolumab at the reduced dose of 1 mg/kg)
• Signs of or symptoms of active graft versus host disease
• Active pneumonitis or uncontrolled infection
• Received chemotherapy drugs within previous 2 weeks
• Estimated life expectancy < 28 days in the opinion of the enrolling investigator