Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03300843 · OUTCOME

Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide

Ability of a Dendritic Cell Vaccine to Immunize Melanoma or Epithelial Cancer Patients Against Defined Mutated Neoantigens Expressed by the Autologous Cancer · Source last updated 2019-12-13

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 0, Day 14 (± 5 d), Day 28 (± 5 d), and Day 42 (± 5 d)

What was measured

Enzyme-linked immunosorbent assay (ELISA) and enzyme-linked immune absorbent spot (ELISpot) assays assessed reactivity to the mutated peptide compared to the non-mutated peptide. Differences of 2-3 fold in these assays over the baseline measurement are indicative of true biologic differences.

Groups in this outcome

Peptide Loaded Dendritic Cell Vaccine

Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.

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

Analysis denominator · Participants

GroupSource count
Peptide Loaded Dendritic Cell Vaccine1

Reported measurements

Mutated peptide Day 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peptide Loaded Dendritic Cell Vaccine0Not reportedNot reportedNot reportedNot reported
Mutated peptide Day 14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peptide Loaded Dendritic Cell Vaccine0Not reportedNot reportedNot reportedNot reported
Mutated peptide Day 28
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peptide Loaded Dendritic Cell Vaccine0Not reportedNot reportedNot reportedNot reported
Mutated peptide Day 42
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peptide Loaded Dendritic Cell Vaccine0Not reportedNot reportedNot reportedNot reported
Non-Mutated peptide Day 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peptide Loaded Dendritic Cell Vaccine0Not reportedNot reportedNot reportedNot reported
Non-Mutated peptide Day 14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peptide Loaded Dendritic Cell Vaccine0Not reportedNot reportedNot reportedNot reported
Non-Mutated peptide Day 28
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peptide Loaded Dendritic Cell Vaccine0Not reportedNot reportedNot reportedNot reported
Non-Mutated peptide Day 56
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peptide Loaded Dendritic Cell Vaccine0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Mutated peptide Day 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Mutated peptide Day 14
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Mutated peptide Day 28
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Mutated peptide Day 42
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Non-Mutated peptide Day 0
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Non-Mutated peptide Day 14
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Non-Mutated peptide Day 28
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Non-Mutated peptide Day 56
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Enzyme-linked immunosorbent assay (ELISA) and enzyme-linked immune absorbent spot (ELISpot) assays assessed reactivity to the mutated peptide compared to the non-mutated peptide. Differences of 2-3 fold in these assays over the baseline measurement are indicative of true biologic differences.
groups
  1. description
    Peptide loaded dendritic cell vaccine on days 0, 14, 28, and 42 Peptide loaded dendritic cell vaccine: On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.
    id
    OG000
    title
    Peptide Loaded Dendritic Cell Vaccine
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Day 0, Day 14 (± 5 d), Day 28 (± 5 d), and Day 42 (± 5 d)
title
Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice