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NCT02431559 · OUTCOME

Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method

Phase 1/2 Study of Motolimod, Doxorubicin, and Durvalumab in Recurrent, Platinum-Resistant Ovarian Cancer · Source last updated 2022-10-10

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
Up to 36.6 months

What was measured

After completion of treatment, all subjects are followed for survival every 3 months for up to 3 years following initiation of study treatment or or for subjects continuing treatment, completion of study treatment whichever was longer. OS is measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up are censored on the date when they were last known to be alive.

Analysis population: The population comprises all subjects who received at least one dose of study treatment.

Groups in this outcome

Phase 1, Dose Level 0a

Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.

Phase 1, Dose Level 0b

Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.

Phase 1, Dose Level +1

Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.

Phase 2

Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.

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

Analysis denominator · Participants

GroupSource count
Phase 1, Dose Level 0a3
Phase 1, Dose Level 0b4
Phase 1, Dose Level +16
Phase 240

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1, Dose Level 0a27.7Not reported11.8NAUpper limit of confidence interval was not estimable due to small number of patients with events.
Phase 1, Dose Level 0bNANot reported4.2NAMedian OS for Phase 1, Dose Level 0b and upper limit of confidence interval were not estimable due to small number of patients with events.
Phase 1, Dose Level +112.8Not reported4.0NAUpper limit of confidence interval was not estimable due to small number of patients with events.
Phase 217.6Not reported11.6NAUpper limit of confidence interval was not estimable due to small number of patients with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of confidence interval was not estimable due to small number of patients with events.
        group Id
        OG000
        lower Limit
        11.8
        upper Limit
        NA
        value
        27.7
      2. comment
        Median OS for Phase 1, Dose Level 0b and upper limit of confidence interval were not estimable due to small number of patients with events.
        group Id
        OG001
        lower Limit
        4.2
        upper Limit
        NA
        value
        NA
      3. comment
        Upper limit of confidence interval was not estimable due to small number of patients with events.
        group Id
        OG002
        lower Limit
        4.0
        upper Limit
        NA
        value
        12.8
      4. comment
        Upper limit of confidence interval was not estimable due to small number of patients with events.
        group Id
        OG003
        lower Limit
        11.6
        upper Limit
        NA
        value
        17.6
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      40
    units
    Participants
description
After completion of treatment, all subjects are followed for survival every 3 months for up to 3 years following initiation of study treatment or or for subjects continuing treatment, completion of study treatment whichever was longer. OS is measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up are censored on the date when they were last known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
    id
    OG000
    title
    Phase 1, Dose Level 0a
  2. description
    Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
    id
    OG001
    title
    Phase 1, Dose Level 0b
  3. description
    Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
    id
    OG002
    title
    Phase 1, Dose Level +1
  4. description
    Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
    id
    OG003
    title
    Phase 2
param Type
MEDIAN
population Description
The population comprises all subjects who received at least one dose of study treatment.
reporting Status
POSTED
time Frame
Up to 36.6 months
title
Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice