Brief Title
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of 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
Brief Summary
This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and
pembrolizumab in hematologic malignancies.
Detailed Description
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).
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With Treatment Emergent Adverse Events (AEs)
Secondary Outcome
Overall Response Rate
Condition
Follicular Lymphoma (FL)
Intervention
Acalabrutinib
Study Arms / Comparison Groups
Acalabrutinib plus Pembrolizumab
Description: A nonrandomized study that will be conducted in 2 stages. In the first stage, (Safety), subjects will receive Acalabrutinib Dose A orally administered (PO) twice daily (BID) in combination with Pembrolizumab Dose B administered every 3 weeks (Q3W). The second stage was an expansion of Cohorts with the same dose regimen as the first stage. An additional expansion in subjects with Myelofibrosis was planned but not conducted.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
161
Start Date
February 20, 2015
Completion Date
December 31, 2025
Primary Completion Date
July 14, 2020
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
AstraZeneca Clinical Study Information Center, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02362035
Organization ID
ACE-LY-005
Responsible Party
Sponsor
Study Sponsor
Acerta Pharma BV
Collaborators
Merck Sharp & Dohme LLC
Study Sponsor
AstraZeneca Clinical Study Information Center, Study Director, 1-877-240-9479 - [email protected]
Verification Date
January 2023