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NCT02554812 · OUTCOME

OS for Combination C

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) · Source last updated 2024-07-30

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
From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)

What was measured

OS was defined as the time (in months) from the date of first dose of study drug to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at the date of last contact. OS was analyzed by Kaplan-Meier method.

Analysis population: Full analysis set included all enrolled participants who received at least one dose of study drug.

Groups in this outcome

Combination C Phase 1b: PD 0360324 50 mg + Avelumab

During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Combination C Phase 1b: PD 0360324 100 mg + Avelumab

During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination C Phase 1b: PD 0360324 150 mg + Avelumab

During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

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

Analysis denominator · Participants

GroupSource count
Combination C Phase 1b: PD 0360324 50 mg + Avelumab10
Combination C Phase 1b: PD 0360324 100 mg + Avelumab8
Combination C Phase 1b: PD 0360324 150 mg + Avelumab6

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab16.3Not reported0.5NAUpper limit of 95% CI was not estimable as there were less number of participants with an event.
Combination C Phase 1b: PD 0360324 100 mg + Avelumab30.9Not reported1.1NAUpper limit of 95% CI was not estimable as there were less number of participants with an event.
Combination C Phase 1b: PD 0360324 150 mg + Avelumab17.3Not reported6.3NAUpper limit of 95% CI was not estimable as there were less number of participants with an event.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% CI was not estimable as there were less number of participants with an event.
        group Id
        OG000
        lower Limit
        0.5
        upper Limit
        NA
        value
        16.3
      2. comment
        Upper limit of 95% CI was not estimable as there were less number of participants with an event.
        group Id
        OG001
        lower Limit
        1.1
        upper Limit
        NA
        value
        30.9
      3. comment
        Upper limit of 95% CI was not estimable as there were less number of participants with an event.
        group Id
        OG002
        lower Limit
        6.3
        upper Limit
        NA
        value
        17.3
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      6
    units
    Participants
description
OS was defined as the time (in months) from the date of first dose of study drug to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at the date of last contact. OS was analyzed by Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    During Phase 1b participants received PD 0360324 50 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
    id
    OG000
    title
    Combination C Phase 1b: PD 0360324 50 mg + Avelumab
  2. description
    During Phase 1b participants received PD 0360324 100 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
    id
    OG001
    title
    Combination C Phase 1b: PD 0360324 100 mg + Avelumab
  3. description
    During Phase 1b participants received PD 0360324 150 mg IV Q2W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
    id
    OG002
    title
    Combination C Phase 1b: PD 0360324 150 mg + Avelumab
param Type
MEDIAN
population Description
Full analysis set included all enrolled participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
title
OS for Combination C
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice