Clinical TrialsThe James Cancer Center Columbus, OH
open for enrollment
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies
A Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects with B-cell Malignancies
This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib
and pembrolizumab in hematologic malignancies.
Are you eligible?
Diagnosis of a hematologic malignancy as documented by medical records and with
histology based on criteria established by the World Health Organization (WHO).
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
Agreement to use contraception during the study and for 90 days after the last dose
of ACP-196 or 120 days after the last dose of pembrolizumab, if sexually active and
able to bear or beget children.
Completion of all therapy (including surgery, radiotherapy, chemotherapy,
immunotherapy, or investigational therapy) for the treatment of cancer ≥ 4 weeks
before the start of study therapy.
ANC ≥ 0.5 x 10^9/L or platelet count ≥ 50 x 10^9/L unless due to disease involvement
in the bone marrow.
A life-threatening illness, medical condition or organ system dysfunction which, in
the investigator's opinion, could compromise the subject's safety, interfere with the
absorption or metabolism of study drugs, or put the study outcomes at undue risk.
Central nervous system (CNS) involvement by lymphoma/leukemia
Any therapeutic antibody within 4 weeks of first dose of study drugs.
Total bilirubin > 1.5 x ULN; and aspartate aminotransferase (AST) or alanine
aminotransferase (ALT) > 3.0 x ULN.
Estimated creatinine clearance of < 30 mL/min, calculated using the formula of
Cockcroft and Gault (140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85