Trials / Completed
CompletedNCT02362035
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 (Acalabrutinib) and Pembrolizumab in Subjects With Hematologic Malignancies
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 161 (actual)
- Sponsor
- Acerta Pharma BV · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acalabrutinib | Orally Administered (PO) |
| DRUG | Pembrolizumab | Intravenous Administered (IV) |
Timeline
- Start date
- 2015-02-20
- Primary completion
- 2020-07-14
- Completion
- 2025-10-27
- First posted
- 2015-02-12
- Last updated
- 2025-12-11
- Results posted
- 2022-05-06
Locations
19 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02362035. Inclusion in this directory is not an endorsement.