Ibrutinib and PD-1 Blockade in High Risk Lymphocytic Leukemia

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Janssen Scientific Affairs, LLC; Merck Sharp & Dohme Corp.
• Treatments: Pembrolizumab

Criteria

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