ACP-196 (Acalabrutinib) in Combination with Pembrolizumab, for Treatment of Hematologic Malignancies - KEYNOTE145
Study identifier:ACE-LY-005
ClinicalTrials.gov identifier:NCT02362035
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 (Acalabrutinib) and Pembrolizumab in Subjects with Hematologic Malignancies
Medical condition
Follicular lymphoma (FL)
Phase
Phase 1/2
Healthy volunteers
No
Study drug
Acalabrutinib, Pembrolizumab
Sex
All
Actual Enrollment
161
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 20 Feb 2015
Primary Completion Date: 14 Jul 2020
Estimated Study Completion Date: 01 Apr 2026
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2024 by AcertaPharma
Sponsors
AcertaPharma
Collaborators
Merck
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Acalabrutinib plus Pembrolizumab 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. | Drug: Acalabrutinib Orally Administered (PO) Other Name: ACP-196 Drug: Pembrolizumab Intravenous Administered (IV) Other Name: KEYTRUDA |
Contacts
Investigators
Principal Investigator
AstraZeneca Clinical Study Information Center
1-877-240-9479 - [email protected]
