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NCT03358719 · OUTCOME

Peripheral Blood and Bone Marrow Cells Responses

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 methylated cytosines
Interval / dispersion
Standard Deviation
Time frame
Cycle 1- 4 weekly to EOT (up to 180 days from baseline)

What was measured

The degree of DNA methylation at CpG sites within the promoter of the tumor antigen NY-ESO-1 was quantified. Results are reported as the percentage of methylated cytosines relative to the total cytosines at the analyzed CpG sites.

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)8

Reported measurements

Baseline (Day 0)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)8
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)84.54.9Not reportedNot reportedNot reported
Cycle 1 Week 1 (approximately 1 week from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)3
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)817.8Not reportedNot reportedNot reported
Cycle 1 Week 2 (approximately 2 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)8
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)70.29.3Not reportedNot reportedNot reported
Cycle 1 Week 3 (approximately 3 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)2
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)73.50.71Not reportedNot reportedNot reported
Cycle 1 Week 4 (approximately 4 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)5
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)76.66.8Not reportedNot reportedNot reported
Cycle 2 Week 1 (approximately 5 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)7
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)85.15.5Not reportedNot reportedNot reported
Cycle 2 Week 2 (approximately 6 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)6
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)62.313.7Not reportedNot reportedNot reported
Cycle 2 Week 3 (approximately 7 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)8
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)729.3Not reportedNot reportedNot reported
Cycle 2 Week 4 (approximately 8 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)8
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)76.98.5Not reportedNot reportedNot reported
Cycle 3 Week 1 (approximately 9 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)2
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)82.5.71Not reportedNot reportedNot reported
Cycle 3 Week 2 (approximately 10 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)2
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)54.124.3Not reportedNot reportedNot reported
Cycle 3 Week 3 (approximately 11 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)4
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)74.32.8Not reportedNot reportedNot reported
Cycle 4 Week 1 (approximately 12 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)7
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)72.412.4Not reportedNot reportedNot reported
Cycle 4 Week 2 (approximately 13 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)7
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)59.712.4Not reportedNot reportedNot reported
Cycle 4 Week 3 (approximately 14 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)6
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)765.5Not reportedNot reportedNot reported
Cycle 4 Week 4 (approximately 15 weeks from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)6
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)76.311.7Not reportedNot reportedNot reported
End of Treatment (up to 180 days from baseline)

Analysis denominator · Participants

GroupSource count
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)3
Values in percentage of methylated cytosines · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)85.71.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.9
        value
        84.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Baseline (Day 0)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.8
        value
        81
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Cycle 1 Week 1 (approximately 1 week from baseline)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.3
        value
        70.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Cycle 1 Week 2 (approximately 2 weeks from baseline)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.71
        value
        73.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Cycle 1 Week 3 (approximately 3 weeks from baseline)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.8
        value
        76.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Cycle 1 Week 4 (approximately 4 weeks from baseline)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.5
        value
        85.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Cycle 2 Week 1 (approximately 5 weeks from baseline)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.7
        value
        62.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Cycle 2 Week 2 (approximately 6 weeks from baseline)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.3
        value
        72
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Cycle 2 Week 3 (approximately 7 weeks from baseline)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.5
        value
        76.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Cycle 2 Week 4 (approximately 8 weeks from baseline)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        .71
        value
        82.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Cycle 3 Week 1 (approximately 9 weeks from baseline)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.3
        value
        54.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Cycle 3 Week 2 (approximately 10 weeks from baseline)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.8
        value
        74.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 3 Week 3 (approximately 11 weeks from baseline)
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
The degree of DNA methylation at CpG sites within the promoter of the tumor antigen NY-ESO-1 was quantified. Results are reported as the percentage of methylated cytosines relative to the total cytosines at the analyzed CpG sites.
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
Cycle 1- 4 weekly to EOT (up to 180 days from baseline)
title
Peripheral Blood and Bone Marrow Cells Responses
type
SECONDARY
unit Of Measure
percentage of methylated cytosines

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

Preserved source evidence · Not medical advice