Multiple Phase 1 Safety Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies

Inclusion Criteria
ECOG Performance of 0 or 1
Subjects must have histological confirmation of relapsed or refractory hematologic malignancy
Life expectancy of at least 3 months
Prior palliative radiation must have been completed at least 2 weeks prior to Day 1
Toxicities related to prior therapy must have returned to Grade 1 or less, except for alopecia
Adequate bone marrow function
Adequate renal function
Adequate liver function
Women must not be breastfeeding
Exclusion Criteria
Subjects with myelodysplasia, polycythemia vera, idiopathic thrombocythemia, myelofibrosis, acute leukemias, or CML
Subjects with a history of central nervous system involvement by hematologic malignancy or symptoms suggestive of central nervous system involvement
Subjects with a history of chest radiation less than or equal to 24 weeks prior to first dose of study medication
Subjects with concomitant second malignancies are excluded unless a complete remission was achieved as it is empirically determined based on the malignancy and treatment provided prior to study entry and no additional therapy is required or anticipated to be required during the study period
Subjects with active, known, or suspected autoimmune disease
A serious uncontrolled medical disorder or active infection which would impair the ability of the subject to receive protocol therapy or whose control may be jeopardized by the complications of this therapy
Deep vein thrombosis not adequately controlled
Uncontrolled or significant cardiovascular disease
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody
Non-oncology vaccine therapies for prevention of infectious diseases within 4 weeks of study drug administration
Prior organ allograft or allogeneic bone marrow transplantation
Positive for human immunodeficiency virus (HIV 1/2) antibody, or known acquired immunodeficiency syndrome (AIDS)
Hepatitis B surface antigen positive, or history of active chronic hepatitis B
Hepatitis C antibody positive, or history of active chronic hepatitis C
History of Grade 4 anaphylactic reaction to monoclonal antibody therapy
Intolerance to prior IMiD
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness