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