Clinical trial · Interventional
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
NCT02362035CI-TRIAL-00111330KEYNOTE145completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Burkitt Lymphoma | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Follicular Lymphoma (FL) | Follicular Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Hairy Cell Leukemia | Hairy Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Indolent Non Hodgkin Lymphoma | Indolent Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mantle Cell Lymphoma (MCL) | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Marginal Zone Lymphomas | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Mediastinal Large B Cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acalabrutinib | Drug | Acalabrutinib | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: Acalabrutinib
- Drug: Pembrolizumab
Primary outcomes (16)
- measure
- Number of Participants With Treatment Emergent Adverse Events (AEs)
- timeFrame
- 104 weeks
- description
- Treatment-emergent AEs were defined as those events that occurred on or after the first dose of study drug, through the treatment phase, and within 30 days following the last dose of study drug.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.