Phase 2
N=161
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies
Follicular Lymphoma (FL) · CLL · Small Lymphocytic Lymphoma (SLL) · Richter's Syndrome · Mantle Cell Lymphoma (MCL)
Bottom Line
View on ClinicalTrials.gov: NCT02362035 ↗Enrolled (actual)
161
Serious AEs
46.6%
Results posted
May 2022
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (AEs) — 160 Number of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Acalabrutinib (Drug); Pembrolizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Acerta Pharma BV
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) |
160 | — |
| PRIMARY Number of Participants With Grade 3-4 Adverse Events |
105 | — |
| PRIMARY Number of Participants With Grade 5 Adverse Events |
9 | — |
| PRIMARY Number of Participants With Any Study-Drug Related AE |
142 | — |
| PRIMARY Number of Participants With Grade 3-4 Study-Drug Related AE |
66 | — |
| PRIMARY Number of Participants With Grade 5 Study-Drug Related AE |
3 | — |
| PRIMARY Number of Participants With Any SAE |
75 | — |
| PRIMARY Number of Participants With Grade 3-4 Any SAE |
64 | — |
| PRIMARY Number of Participants With Grade 5 Any SAE |
9 | — |
| PRIMARY Number of Participants With Any Study Drug-Related SAE |
34 | — |
| PRIMARY Number of Participants With Any Grade 3-4 Study Drug-Related SAE |
30 | — |
| PRIMARY Number of Participants With Any Grade 5 Study Drug-Related SAE |
3 | — |
| PRIMARY Number of Participants With AE Leading to Study Drug Discontinuation, Modification or Delay |
83 | — |
| PRIMARY Number of Participants With AE Leading to Study Drug Discontinuation |
45 | — |
| PRIMARY Number of Participants With AE Leading to Study Drug Delay |
71 | — |
| PRIMARY Number of Participants With AE Leading to Study Drug Modification |
9 | — |
| SECONDARY Overall Response Rate |
38.5 | — |
| SECONDARY Duration of Response |
28.5 | — |
| SECONDARY Progression-free Survival |
4.7 | — |
| SECONDARY Overall Survival |
50.4 | — |
| SECONDARY Time to Next Treatment |
21.1 | — |
Summary
This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.
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.
Data sourced from ClinicalTrials.gov (NCT02362035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.