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NCT03358719 · OUTCOME

Proportion or Participants Experiencing a Dose-limiting Toxicity

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Up to 180 days

What was measured

Will evaluate the proportion of n=8 evaluable patients in the expansion cohort experiencing a dose-limiting toxicity. Toxicity rates will be described using upper 1-sided 95% Jeffreys binomial confidence intervals.

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

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab)0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Will evaluate the proportion of n=8 evaluable patients in the expansion cohort experiencing a dose-limiting toxicity. Toxicity rates will be described using upper 1-sided 95% Jeffreys binomial confidence intervals.
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
NUMBER
population Description
All treated and eligible patients
reporting Status
POSTED
time Frame
Up to 180 days
title
Proportion or Participants Experiencing a Dose-limiting Toxicity
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice