Clinical Trials Search
Phase II Trial of Ibrutinib and PD-1 Blockade in High Risk Chronic Lymphocytic Leukemia to Improve Immune Function.
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.
Primary: 1. Assessment of the overall response rate (ORR) of CLL to therapeutic intervention (defined per current iWCLL 2008 response criteria). 2. Time to response of CLL to therapeutic intervention (defined as time to achievement of response according to iWCLL 2008 criteria). Secondary Objectives: 1. Restoration of immune response as measured by: a. Decreased markers of T-cell exhaustion. b. Increased of quantitative immunoglobulin levels and subtype. 2. Safety and toxicity of the combination. 3. Progression free survival (PFS). 4. Incidence of Richter's transformation.
748645 (Ibrutinib); Ibrutinib (Imbruvica); PCI-32765 (Ibrutinib); Pembrolizumab (Keytruda)