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NCT03439085 · OUTCOME

Median Overall Survival

DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine INO-3112 and Durvalumab in Treating Patients With Recurrent or Metastatic Human Papillomavirus Associated Cancers · Source last updated 2024-07-09

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 2 years

What was measured

Will be summarized using the method of Kaplan and Meier and Cox proportional hazards models.

Analysis population: The cervical cancer cohort had 12 participants. The non cervical cohort had 9 participants.

Groups in this outcome

Treatment Group

Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.

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 Group21

Reported measurements

Entire Population

Analysis denominator · Participants

GroupSource count
Treatment Group21
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Group17.7Not reported7.6NAupper limit of the confidence interval was not estimable due to an insufficient number of participants with events
Cervical Cancer Cohort

Analysis denominator · Participants

GroupSource count
Treatment Group12
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Group7.6Not reported3.717.7Not reported
Non Cervical Cohort

Analysis denominator · Participants

GroupSource count
Treatment Group9
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Group0Not reportedNANAinsufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        upper limit of the confidence interval was not estimable due to an insufficient number of participants with events
        group Id
        OG000
        lower Limit
        7.6
        upper Limit
        NA
        value
        17.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      units
      Participants
    title
    Entire Population
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.7
        upper Limit
        17.7
        value
        7.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Cervical Cancer Cohort
  3. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Non Cervical Cohort
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Will be summarized using the method of Kaplan and Meier and Cox proportional hazards models.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received 7 mg of MEDI0457 intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks starting at week 4.
    id
    OG000
    title
    Treatment Group
param Type
MEDIAN
population Description
The cervical cancer cohort had 12 participants. The non cervical cohort had 9 participants.
reporting Status
POSTED
time Frame
Up to 2 years
title
Median Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice