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ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies (KEYNOTE145)

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ClinicalTrials.gov Identifier: NCT02362035
Recruitment Status : Active, not recruiting
First Posted : February 12, 2015
Last Update Posted : May 22, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.

Condition or disease Intervention/treatment Phase
Non-hodgkin Lymphoma Multiple Myeloma Hodgkin Lymphoma Chronic Lymphocytic Leukemia Richter's Syndrome Waldenstrom Macroglobulinemia Drug: Acalabrutinib Drug: Pembrolizumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 (Acalabrutinib) and Pembrolizumab in Subjects With Hematologic Malignancies
Study Start Date : February 2015
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
Experimental: Safety Review
The safety and preliminary efficacy of the combination of acalabrutinib and pembrolizumab will be reviewed
Drug: Acalabrutinib
oral

Drug: Pembrolizumab
intravenous
Other Name: KEYTRUDA




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: 104 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • 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.

Main Exclusion Criteria:

  • 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 if female.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362035


Locations
United States, Washington
Vancouver, Washington, United States
Sponsors and Collaborators
Acerta Pharma BV
Merck Sharp & Dohme Corp.
Investigators
Study Director: Dih-Yih Chen, MD Acerta Pharma, LLC

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02362035     History of Changes
Other Study ID Numbers: ACE-LY-005
First Posted: February 12, 2015    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017

Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Btk
B-Cell Malignancies
Mantle Cell
Multiple Myeloma
CLL
SLL
DLBCL
Follicular
Waldenstrom
Burkitt lymphoma
marginal zone lymphomas
hairy cell leukemia
B cell acute lymphoid leukemia
Acalabrutinib
ACP-196

Additional relevant MeSH terms:
Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Hodgkin Disease
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Leukemia, B-Cell
Pembrolizumab
Antineoplastic Agents