Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Terminated; Phase 2

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: Pembrolizumab; Drug: Ibrutinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03514017

MCC-19199

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Pembrolizumab and Ibrutinib

Experimental group

Description:

Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months. Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.

Treatment:

Drug: Ibrutinib

Drug: Pembrolizumab