Summary
This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.
Official Title
A Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 (Acalabrutinib) and Pembrolizumab in Subjects With Hematologic Malignancies
Details
This is a Phase 1b/2, open-label, nonrandomized study that will be conducted in 2 stages. In the first stage, Part 1 of the study will determine the safety and preliminary efficacy of acalabrutinib and pembrolizumab in a limited group of B-cell malignancies. In the second stage, Part 2 allows for possible expansion cohorts into a wider range of B-cell malignancies, and Part 3 will evaluate the combination in subjects with myelofibrosis (MF).
Keywords
Follicular Lymphoma (FL), CLL, Small Lymphocytic Lymphoma (SLL), Richter's Syndrome, Mantle Cell Lymphoma (MCL), Indolent Non Hodgkin Lymphoma, Waldenström Macroglobulinemia, Multiple Myeloma, Hodgkin Lymphoma, Burkitt Lymphoma, Marginal Zone Lymphomas, Mediastinal Large B Cell Lymphoma, Hairy Cell Leukemia, Bruton tyrosine kinase inhibitor, Btk, B-Cell Malignancies, Mantle Cell, SLL, DLBCL, Follicular, Waldenstrom, B cell acute lymphoid leukemia, Acalabrutinib, ACP-196, Lymphoma, Leukemia, Neoplasms, Mantle-Cell Lymphoma, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Neoplasms, Waldenstrom Macroglobulinemia, Pembrolizumab, Acalabrutinib plus Pembrolizumab