Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia

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