Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia
The purpose of this study is to evaluate the impact of sequential overlapping treatment with
 PD-1 monoclonal antibody (mAb), pembrolizumab/MK-1375, followed by ibrutinib on endogenous
 immune function in previously untreated, high-risk CLL patients. Immune function will be
 evaluated through various laboratory correlative tests.
Inclusion Criteria:

 -  Have high risk CLL

 -  Have documented previously untreated CLL according to IWCLL criteria

 -  Willing and able to provide written informed consent

 -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

 -  Demonstrate adequate organ function

 -  Able to take oral medication and willing to adhere to the medication regimen

 Exclusion Criteria:

 -  Currently participating in or has participated in a study of an investigational agent
 or using an investigational device within 4 weeks of the first dose of treatment

 -  Meets IWCLL criteria to start therapy

 -  Has had any treatment for CLL including any investigational agent, chemotherapy, mAb,
 anti-PD-1, anti-PDL-1, or anti-CTLA-4

 -  Transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic
 leukemia)

 -  Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

 -  Is pregnant or breastfeeding, or expecting to conceive or father children within the
 projected duration of the trial, starting with the pre-screening or screening visit
 through 90 days after the last dose of trial treatment

 -  Major surgery or a wound that has not fully healed within 4 weeks of first dose

 -  Additional criteria may apply