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NCT02554812 · OUTCOME

Phase 1b: Percentage of Participants With Objective Response (OR) 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From first dose of study drug until disease progression or death due to any cause (maximum up to 7.3 years)

What was measured

OR as assessed by investigator per RECIST v.1.1, was defined as participants with confirmed best overall response of CR or PR, were recorded from first dose of study drug until disease progression or death due to any cause. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as \>=30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.

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 Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab10.0Not reported0.344.5Not reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab25.0Not reported3.265.1Not reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab16.7Not reported0.464.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.3
        upper Limit
        44.5
        value
        10.0
      2. group Id
        OG001
        lower Limit
        3.2
        upper Limit
        65.1
        value
        25.0
      3. group Id
        OG002
        lower Limit
        0.4
        upper Limit
        64.1
        value
        16.7
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      6
    units
    Participants
description
OR as assessed by investigator per RECIST v.1.1, was defined as participants with confirmed best overall response of CR or PR, were recorded from first dose of study drug until disease progression or death due to any cause. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 mm. PR was defined as \>=30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.
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
NUMBER
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 until disease progression or death due to any cause (maximum up to 7.3 years)
title
Phase 1b: Percentage of Participants With Objective Response (OR) for Combination C
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice