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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02362035
Other study ID # ACE-LY-005
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date February 20, 2015
Est. completion date April 1, 2026

Study information

Verified date April 2024
Source Acerta Pharma BV
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 161
Est. completion date April 1, 2026
Est. primary completion date July 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Burkitt Lymphoma
  • CLL
  • Follicular Lymphoma (FL)
  • Hairy Cell Leukemia
  • Hematologic Neoplasms
  • Hodgkin Lymphoma
  • Indolent Non Hodgkin Lymphoma
  • Leukemia
  • Leukemia, Hairy Cell
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell
  • Mantle Cell Lymphoma (MCL)
  • Marginal Zone Lymphomas
  • Mediastinal Large B Cell Lymphoma
  • Multiple Myeloma
  • Neoplasms
  • Richter's Syndrome
  • Small Lymphocytic Lymphoma (SLL)
  • Waldenstrom Macroglobulinemia
  • Waldenström Macroglobulinemia

Intervention

Drug:
Acalabrutinib
Orally Administered (PO)
Pembrolizumab
Intravenous Administered (IV)

Locations

Country Name City State
United States Research Site Boston Massachusetts
United States Research Site Columbus Ohio
United States Research Site Dallas Texas
United States Research Site Denver Colorado
United States Research Site Fairfax Virginia
United States Research Site Greenville South Carolina
United States Research Site Houston Texas
United States Research Site Los Angeles California
United States Research Site Nashville Tennessee
United States Research Site Niles Illinois
United States Research Site Omaha Nebraska
United States Research Site Roanoke Virginia
United States Research Site Rochester Minnesota
United States Research Site San Antonio Texas
United States Research Site Tucson Arizona
United States Research Site Tyler Texas
United States Research Site Vancouver Washington
United States Research Site Washington District of Columbia
United States Research Site Yakima Washington

Sponsors (2)

Lead Sponsor Collaborator
Acerta Pharma BV Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 104 weeks
Primary Number of Participants With Grade 3-4 Adverse Events Severity of AEs was graded using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03 104 weeks
Primary Number of Participants With Grade 5 Adverse Events Number of participants with CTCAE Grade 5 (fatal) adverse events 104 weeks
Primary Number of Participants With Any Study-Drug Related AE Study drug-related AEs were those assessed by investigator as related to study treatment. 104 weeks
Primary 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. 104 weeks
Primary Number of Participants With Grade 5 Study-Drug Related AE Grade 5 (fatal) AEs assessed by investigator as related to study treatment. 104 weeks
Primary 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. 104 weeks
Primary 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. 104 weeks
Primary 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. 104 weeks
Primary 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. 104 weeks
Primary 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. 104 weeks
Primary 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. 104 weeks
Primary 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. 104 weeks
Primary 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. 104 weeks
Primary Number of Participants With AE Leading to Study Drug Delay An adverse event that caused a temporary withholding of study treatment. 104 weeks
Primary 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. 104 weeks
Secondary Overall Response Rate The percentage of subjects who achieve a partial response or complete response 104 weeks
Secondary 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 104 weeks
Secondary 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 104 weeks
Secondary Overall Survival The time from the first dose date of acalabrutinib or pembrolizumab until date of death due to any cause 104 weeks
Secondary 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 104 weeks
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