Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03358719 · FLOW

Participant flow

DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia · Source last updated 2026-02-27

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

groups
  1. description
    Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity. DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given intracutaneously Decitabine: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Poly ICLC: Given SC The study originally provided for the possibility of dose de-escalation for the treatment arms, but as we had no dose limiting toxicities, the dose level 1 was declared the maximum administered dose and all patients were enrolled and treated at dose level 1.
    id
    FG000
    title
    Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 30 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity. DEC-205/NY-ESO-1 Fusion Protein CDX-1401: Given intracutaneously Decitabine: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV Poly ICLC: Given SC The study originally provided for the possibility of dose de-escalation for the treatment arms, but as we had no dose limiting toxicities, the dose level 1 was declared the maximum administered dose and all patients were enrolled and treated at dose level 1.
    id
    FG000
    title
    Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice