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Follicular Lymphoma (FL)Phase 1/2KEYNOTE145NCT02362035

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

A Phase 1/2 study testing Acalabrutinib and Pembrolizumab in people with Follicular Lymphoma (FL) and CLL, run by Acerta Pharma BV at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Acalabrutinib and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
19 sitesUnited States
Study dates
20 Feb 2015to 27 Oct 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Research Site

    Boston, Massachusetts, 2215

  • Research Site

    Columbus, Ohio, 43210

  • Research Site

    Dallas, Texas, 75246

  • Research Site

    Denver, Colorado, 80218

  • Research Site

    Fairfax, Virginia, 22031

  • Research Site

    Greenville, South Carolina, 29605

  • Research Site

    Houston, Texas, 77030

  • Research Site

    Los Angeles, California, 90095

  • Research Site

    Nashville, Tennessee, 37203

  • Research Site

    Niles, Illinois, 60714

  • Research Site

    Omaha, Nebraska, 68198-7680

  • Research Site

    Roanoke, Virginia, 24014

  • Research Site

    Rochester, Minnesota, 55905-0001

  • Research Site

    San Antonio, Texas, 78217

  • Research Site

    Tucson, Arizona, 85704

  • Research Site

    Tyler, Texas, 75702

  • Research Site

    Vancouver, Washington, 98684

  • Research Site

    Washington D.C., District of Columbia, 20007

  • Research Site

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: A Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 (Acalabrutinib) and Pembrolizumab in Subjects With Hematologic Malignancies

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

Read the 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).

Being tested
Acalabrutinib, Pembrolizumab
Keywords
Bruton tyrosine kinase inhibitor, Btk, B-Cell Malignancies, Mantle Cell, Multiple Myeloma, CLL, SLL, DLBCL, Follicular, Waldenstrom, Burkitt lymphoma, marginal zone lymphomas, hairy cell leukemia, B cell acute lymphoid leukemia, Acalabrutinib, ACP-196
Medical subject headings
Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Waldenstrom Macroglobulinemia, Multiple Myeloma, Hodgkin Disease, Burkitt Lymphoma, Leukemia, Hairy Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcalabrutinibDrug

    Also called ACP-196

    Orally Administered (PO)

  • PembrolizumabDrug

    Also called KEYTRUDA

    Intravenous Administered (IV)

Study groups in NCT02362035
Study groupRoleWhat they receive
Acalabrutinib plus PembrolizumabExperimentalA 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.
Receives: Drug: Acalabrutinib; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 104 weeks

  2. 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

    Measured: 104 weeks

  3. Number of Participants With Grade 5 Adverse Events

    Number of participants with CTCAE Grade 5 (fatal) adverse events

    Measured: 104 weeks

  4. Number of Participants With Any Study-Drug Related AE

    Study drug-related AEs were those assessed by investigator as related to study treatment.

    Measured: 104 weeks

  5. 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.

    Measured: 104 weeks

  6. Number of Participants With Grade 5 Study-Drug Related AE

    Grade 5 (fatal) AEs assessed by investigator as related to study treatment.

    Measured: 104 weeks

  7. 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.

    Measured: 104 weeks

  8. 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.

    Measured: 104 weeks

  9. 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.

    Measured: 104 weeks

  10. 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.

    Measured: 104 weeks

  11. 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.

    Measured: 104 weeks

  12. 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.

    Measured: 104 weeks

  13. 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.

    Measured: 104 weeks

  14. 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.

    Measured: 104 weeks

  15. Number of Participants With AE Leading to Study Drug Delay

    An adverse event that caused a temporary withholding of study treatment.

    Measured: 104 weeks

  16. 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.

    Measured: 104 weeks

Secondary outcomes (5)

  1. Overall Response Rate

    The percentage of subjects who achieve a partial response or complete response

    Measured: 104 weeks

  2. 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

    Measured: 104 weeks

  3. 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

    Measured: 104 weeks

  4. Overall Survival

    The time from the first dose date of acalabrutinib or pembrolizumab until date of death due to any cause

    Measured: 104 weeks

  5. 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

    Measured: 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2015 (estimated)
  2. Study start20 Feb 2015
  3. Primary completion14 Jul 2020
  4. Study completion27 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02362035
Sponsor's protocol ID
ACE-LY-005
Acronym
KEYNOTE145
Status last verified
Apr 2026
First submitted
7 Feb 2015
Last updated
13 May 2026
Data monitoring committee
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Acalabrutinib and Pembrolizumab in people with Follicular Lymphoma (FL) and CLL, run by Acerta Pharma BV at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (AEs) (time frame: 104 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02362035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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