Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia

• INCLUSION CRITERIA:
• Unequivocal diagnosis of relapsed or refractory acute myeloid leukemia (AML) confirmed by an NIH attending pathologist within 30 days of study enrollment (includes residual AML as confirmed by institutional standards by NIH pathologists
• Received at least one prior AML therapy before study enrollment.
• Ability to comprehend the investigational nature of the study and provide informed consent.
• Be at least 18 years of age on day of signing informed consent.
• Availability of a physician willing to assume clinical care after completion of the study.
• Be willing to provide blood and bone marrow for research as described in the study.
• Have a performance status of less than or equal to 1 on the ECOG Performance Scale
• Demonstrate adequate organ function as defined below, all screening labs should be performed within 14 days of treatment initiation.
• Female subject 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.
• Female subjects of childbearing potential must be willing to use an adequate method of contraception; Contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
• Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
• Adequate Organ Function Laboratory Values: System Laboratory - Value
• Renal

---Serum Creatinine - Less than or equal to 1.5 X upper limit of normal (ULN)

• Hepatic
• Serum total bilirubin Less than or equal to 1.5 X ULN OR
• Direct bilirubin less than or equal to ULN for subjects with total bilirubin levels greater than 1.5 ULN
• AST (SGOT) and ALT(SGPT) Less than or equal to 3 X ULN

EXCLUSION CRITERIA

The subject must be excluded from participating in the trial if the subject:

• Has a diagnosis of acute promyelocytic leukemia (APL)
• Has previously received an allogeneic hematopoietic stem cell transplant.
• Has received AML treatment with an investigational therapy or device within 4 weeks of the first dose of treatment.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Has a known history of active TB (Bacillus Tuberculosis)
• Has hypersensitivity to pembrolizumab or any of its excipients.
• Has hypersensitivity to decitabine or any of its excipients.
• Has received more than two prior cycles of decitabine.
• Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1.
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.

--Note: Subjects who have received cytoreductive therapy with hydroxyurea at any time prior to study Day 1 are an exception to this criterion.

• Has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to previously administered AML therapy agents.
• Note: Subjects with less than or equal to Grade 2 neuropathy are an exception and may qualify for the study.
• Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Has a known additional malignancy that is progressing or requires active treatment. Patients with basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer would not be excluded.
• Has