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NCT02580058 · OUTCOME

Duration of Response (DR) Based on BICR Assessment

A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200) · Source last updated 2023-07-10

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
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.

What was measured

DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR \[disappearance of all target lesions\] or PR \[\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions\]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.

Analysis population: The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. Number analyzed are participants with confirmed CR or PR in the FAS within each treatment group.

Groups in this outcome

Avelumab

Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.

Avelumab + PLD

Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.

Pegylated Liposomal Doxorubicin (PLD)

PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.

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

Analysis denominator · Participants

GroupSource count
Avelumab7
Avelumab + PLD25
Pegylated Liposomal Doxorubicin (PLD)8

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Avelumab9.2Not reported6.4NAThe upper limit of 95% confidence interval (CI) was not estimable due to the small number of events.
Avelumab + PLD8.5Not reported6.1NAThe upper limit of 95% CI was not estimable due to the small number of events.
Pegylated Liposomal Doxorubicin (PLD)13.1Not reported5.5NAThe upper limit of 95% CI was not estimable due to the small number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of 95% confidence interval (CI) was not estimable due to the small number of events.
        group Id
        OG000
        lower Limit
        6.4
        upper Limit
        NA
        value
        9.2
      2. comment
        The upper limit of 95% CI was not estimable due to the small number of events.
        group Id
        OG001
        lower Limit
        6.1
        upper Limit
        NA
        value
        8.5
      3. comment
        The upper limit of 95% CI was not estimable due to the small number of events.
        group Id
        OG002
        lower Limit
        5.5
        upper Limit
        NA
        value
        13.1
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      25
    3. group Id
      OG002
      value
      8
    units
    Participants
description
DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR \[disappearance of all target lesions\] or PR \[\>=30% decrease under the baseline of the sum of diameters of all target measurable lesions\]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
    id
    OG000
    title
    Avelumab
  2. description
    Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
    id
    OG001
    title
    Avelumab + PLD
  3. description
    PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
    id
    OG002
    title
    Pegylated Liposomal Doxorubicin (PLD)
param Type
MEDIAN
population Description
The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. Number analyzed are participants with confirmed CR or PR in the FAS within each treatment group.
reporting Status
POSTED
time Frame
Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.
title
Duration of Response (DR) Based on BICR Assessment
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice