This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
161
Orally Administered (PO)
Intravenous Administered (IV)
Research Site
Tucson, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site
Denver, Colorado, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Niles, Illinois, United States
Research Site
Boston, Massachusetts, United States
Research Site
Rochester, Minnesota, United States
Research Site
Omaha, Nebraska, United States
Research Site
Columbus, Ohio, United States
Research Site
Greenville, South Carolina, United States
...and 9 more locations
Number of Participants With Treatment Emergent Adverse Events (AEs)
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.
Time frame: 104 weeks
Number of Participants With Grade 3-4 Adverse Events
Severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
Time frame: 104 weeks
Number of Participants With Grade 5 Adverse Events
Number of participants with CTCAE Grade 5 (fatal) adverse events
Time frame: 104 weeks
Number of Participants With Any Study-Drug Related AE
Study drug-related AEs were those assessed by investigator as related to study treatment.
Time frame: 104 weeks
Number of Participants With Grade 3-4 Study-Drug Related AE
The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher. Drug-related AEs were those assessed by investigator as related to study treatment.
Time frame: 104 weeks
Number of Participants With Grade 5 Study-Drug Related AE
Grade 5 (fatal) AEs assessed by investigator as related to study treatment.
Time frame: 104 weeks
Number of Participants With Any SAE
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.
Time frame: 104 weeks
Number of Participants With Grade 3-4 Any SAE
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher.
Time frame: 104 weeks
Number of Participants With Grade 5 Any SAE
Grade 5 events were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment.
Time frame: 104 weeks
Number of Participants With Any Study Drug-Related SAE
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. Drug-related AEs were those assessed by investigator as related to study treatment.
Time frame: 104 weeks
Number of Participants With Any Grade 3-4 Study Drug-Related SAE
Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. The severity of the AEs was assessed by NCI CTCAE Version 4.03 or higher. Drug-related AEs were those assessed by investigator as related to study treatment.
Time frame: 104 weeks
Number of Participants With Any Grade 5 Study Drug-Related SAE
Grade 5 AEs were fatal events. Serious AEs were those that resulted in death, were life-threatening, required or prolonged in-patient hospitalization, resulted in persistent or significant disability/incapacity, resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product, or were considered a significant medical event by the investigator based on medical judgment. Drug-related AEs were those assessed by investigator as related to study treatment.
Time frame: 104 weeks
Number of Participants With AE Leading to Study Drug Discontinuation, Modification or Delay
AEs that discontinuation of study treatment, or a reduction in dosage, or a delay (temporary withholding) in treatment.
Time frame: 104 weeks
Number of Participants With AE Leading to Study Drug Discontinuation
An adverse event that resulted in the permanent discontinuation of study treatment in the study.
Time frame: 104 weeks
Number of Participants With AE Leading to Study Drug Delay
An adverse event that caused a temporary withholding of study treatment.
Time frame: 104 weeks
Number of Participants With AE Leading to Study Drug Modification
An adverse event that resulted in a reduction in the dosage of study treatment for that participant.
Time frame: 104 weeks
Overall Response Rate
The percentage of subjects who achieve a partial response or complete response
Time frame: 104 weeks
Duration of Response
The interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause
Time frame: 104 weeks
Progression-free Survival
The interval from the first dose date of acalabrutinib or pembrolizumab to the earlier of the first documentation of objective disease progression or death from any cause
Time frame: 104 weeks
Overall Survival
The time from the first dose date of acalabrutinib or pembrolizumab until date of death due to any cause
Time frame: 104 weeks
Time to Next Treatment
The time from the first dose date of acalabrutinib or pembrolizumab to the start of the next treatment other than the study treatment
Time frame: 104 weeks
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