NCT02362035 · REGISTRY CONDITION SEARCH

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2026-05-13

This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Treatment Emergent Adverse Events (AEs)

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outcome · POSTED

Number of Participants With Grade 3-4 Adverse Events

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outcome · POSTED

Number of Participants With Grade 5 Adverse Events

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outcome · POSTED

Number of Participants With Any Study-Drug Related AE

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outcome · POSTED

Number of Participants With Grade 3-4 Study-Drug Related AE

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outcome · POSTED

Number of Participants With Grade 5 Study-Drug Related AE

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outcome · POSTED

Number of Participants With Any SAE

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outcome · POSTED

Number of Participants With Grade 3-4 Any SAE

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outcome · POSTED

Number of Participants With Grade 5 Any SAE

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outcome · POSTED

Number of Participants With Any Study Drug-Related SAE

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outcome · POSTED

Number of Participants With Any Grade 3-4 Study Drug-Related SAE

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outcome · POSTED

Number of Participants With Any Grade 5 Study Drug-Related SAE

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outcome · POSTED

Number of Participants With AE Leading to Study Drug Discontinuation, Modification or Delay

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outcome · POSTED

Number of Participants With AE Leading to Study Drug Discontinuation

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outcome · POSTED

Number of Participants With AE Leading to Study Drug Delay

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outcome · POSTED

Number of Participants With AE Leading to Study Drug Modification

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outcome · POSTED

Overall Response Rate

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outcome · POSTED

Duration of Response

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Time to Next Treatment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: Acalabrutinib
Drug: Pembrolizumab
label
Acalabrutinib plus Pembrolizumab
type
EXPERIMENTAL

interventions

arm Group Labels
Acalabrutinib plus Pembrolizumab
description
Orally Administered (PO)
name
Acalabrutinib
other Names
ACP-196
type
DRUG
arm Group Labels
Acalabrutinib plus Pembrolizumab
description
Intravenous Administered (IV)
name
Pembrolizumab
other Names
KEYTRUDA
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 161
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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
Number of Participants With Treatment Emergent Adverse Events (AEs)
time Frame
104 weeks
description
Severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
measure
Number of Participants With Grade 3-4 Adverse Events
time Frame
104 weeks
description
Number of participants with CTCAE Grade 5 (fatal) adverse events
measure
Number of Participants With Grade 5 Adverse Events
time Frame
104 weeks
description
Study drug-related AEs were those assessed by investigator as related to study treatment.
measure
Number of Participants With Any Study-Drug Related AE
time Frame
104 weeks
description
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.
measure
Number of Participants With Grade 3-4 Study-Drug Related AE
time Frame
104 weeks
description
Grade 5 (fatal) AEs assessed by investigator as related to study treatment.
measure
Number of Participants With Grade 5 Study-Drug Related AE
time Frame
104 weeks
description
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.
measure
Number of Participants With Any SAE
time Frame
104 weeks
description
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.
measure
Number of Participants With Grade 3-4 Any SAE
time Frame
104 weeks
description
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.
measure
Number of Participants With Grade 5 Any SAE
time Frame
104 weeks
description
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.
measure
Number of Participants With Any Study Drug-Related SAE
time Frame
104 weeks
description
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.
measure
Number of Participants With Any Grade 3-4 Study Drug-Related SAE
time Frame
104 weeks
description
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.
measure
Number of Participants With Any Grade 5 Study Drug-Related SAE
time Frame
104 weeks

secondary Outcomes

description
The percentage of subjects who achieve a partial response or complete response
measure
Overall Response Rate
time Frame
104 weeks
description
The interval from the first documentation of response to the earlier of the first documentation of definitive disease progression or death from any cause
measure
Duration of Response
time Frame
104 weeks
description
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
measure
Progression-free Survival
time Frame
104 weeks
description
The time from the first dose date of acalabrutinib or pembrolizumab until date of death due to any cause
measure
Overall Survival
time Frame
104 weeks
description
The time from the first dose date of acalabrutinib or pembrolizumab to the start of the next treatment other than the study treatment
measure
Time to Next Treatment
time Frame
104 weeks

Full study description

brief 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).

Source references