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NCT03358719 · OUTCOME

Immune Cell Profile

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.

Measure
MEAN
Unit
percentage of CD45⁺ leukocytes
Interval / dispersion
Standard Deviation
Time frame
Up to 180 days

What was measured

Descriptive statistics will be used to evaluate the Immune cell profile in the peripheral blood and bone marrow following combination therapy using mass cytometry.

Analysis population: All treated and eligible patients

Groups in this outcome

Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)6

Reported measurements

Pre Conventional dendritic cells type 1 (Cycle 1)
Values in percentage of CD45⁺ leukocytes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)0.00302016670.0050996289Not reportedNot reportedNot reported
Pre Conventional dendritic cells type 2 (Cycle 2)
Values in percentage of CD45⁺ leukocytes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)0.1527850.1900236337Not reportedNot reportedNot reported
Pre Plasmacytoid dendritic cells (Cycle 1)
Values in percentage of CD45⁺ leukocytes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)0.12466166670.1795932594Not reportedNot reportedNot reported
Post Conventional dendritic cells type 1 (Cycle1)
Values in percentage of CD45⁺ leukocytes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)0.00381766670.0054418615Not reportedNot reportedNot reported
Post Conventional dendritic cells type 2 (Cycle 2)
Values in percentage of CD45⁺ leukocytes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)0.14216666670.1900236337Not reportedNot reportedNot reported
Post Plasmacytoid dendritic cells (Cycle 2)
Values in percentage of CD45⁺ leukocytes · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)0.08371166670.1795932594Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0050996289
        value
        0.0030201667
    title
    Pre Conventional dendritic cells type 1 (Cycle 1)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1900236337
        value
        0.152785
    title
    Pre Conventional dendritic cells type 2 (Cycle 2)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1795932594
        value
        0.1246616667
    title
    Pre Plasmacytoid dendritic cells (Cycle 1)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0054418615
        value
        0.0038176667
    title
    Post Conventional dendritic cells type 1 (Cycle1)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1900236337
        value
        0.1421666667
    title
    Post Conventional dendritic cells type 2 (Cycle 2)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1795932594
        value
        0.0837116667
    title
    Post Plasmacytoid dendritic cells (Cycle 2)
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Descriptive statistics will be used to evaluate the Immune cell profile in the peripheral blood and bone marrow following combination therapy using mass cytometry.
dispersion Type
Standard Deviation
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
    OG000
    title
    Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)
param Type
MEAN
population Description
All treated and eligible patients
reporting Status
POSTED
time Frame
Up to 180 days
title
Immune Cell Profile
type
SECONDARY
unit Of Measure
percentage of CD45⁺ leukocytes

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

Preserved source evidence · Not medical advice