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NCT03439085 · OUTCOME

Disease Control Rate

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 2 years

What was measured

Disease control rate is defined as N (%) patients with CR, PR, or SD by 24 weeks on study using RECIST version 1.1. For SD determination for DCR, the patient must have lack of progression for the first 24 weeks on study. Disease control rate will be assessed in the Response-evaluable and As-treated populations. Will be evaluated by RECIST version 1.1. Will be estimated with 95% confidence interval.

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Group37Not reported1662Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16
        upper Limit
        62
        value
        37
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
Disease control rate is defined as N (%) patients with CR, PR, or SD by 24 weeks on study using RECIST version 1.1. For SD determination for DCR, the patient must have lack of progression for the first 24 weeks on study. Disease control rate will be assessed in the Response-evaluable and As-treated populations. Will be evaluated by RECIST version 1.1. Will be estimated with 95% confidence interval.
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
NUMBER
reporting Status
POSTED
time Frame
Up to 2 years
title
Disease Control Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice