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NCT02362035 · FLOW

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ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies · Source last updated 2026-05-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
    id
    FG000
    title
    Acalabrutinib + Pembrolizumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        67
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Subject started another cancer therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        45
      type
      Study terminated by sponsor
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Decision by subject not related to AE/SAE
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Decision by PI not related to AE/SAE
    9. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Disease progression
    10. reasons
      1. group Id
        FG000
        num Subjects
        20
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        161
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        161
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
For the ACE-LY-005 program, Study Terminated by Sponsor refers to the following: Patients receiving treatment benefits will continue to be provided with study medication in the Post Final Analysis Management of the trial. No further data collection for analysis and reporting will be completed after the final Analysis
Complete source fields
groups
  1. description
    All participants in this study received both study drugs and were therefore analysed together as a single treatment arm. Participants receiving the different regimens were not analysed separately by regimen, as the study was designed to assess the safety of the combination study treatment. The study included N=161 participants who received both acalabrutinib and pembrolizumab and are summarized together (from First stage safety lead-in and Second stage expansion). Stage 3 (additional expansion in subjects with Myelofibrosis) was planned but not conducted.
    id
    FG000
    title
    Acalabrutinib + Pembrolizumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        67
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Subject started another cancer therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        45
      type
      Study terminated by sponsor
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Decision by subject not related to AE/SAE
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Decision by PI not related to AE/SAE
    9. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Disease progression
    10. reasons
      1. group Id
        FG000
        num Subjects
        20
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        161
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        161
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
For the ACE-LY-005 program, Study Terminated by Sponsor refers to the following: Patients receiving treatment benefits will continue to be provided with study medication in the Post Final Analysis Management of the trial. No further data collection for analysis and reporting will be completed after the final Analysis

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Preserved source evidence · Not medical advice