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NCT02554812 · OUTCOME

Number of Participants With Positive ADA Levels 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10

What was measured

ADA ever-positive was defined as at least one positive ADA result at any time point.

Analysis population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.

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

ADA ever-positive -Avelumab
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab1Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab0Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab0Not reportedNot reportedNot reportedNot reported
ADA ever-positive -PD 0360324
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination C Phase 1b: PD 0360324 50 mg + Avelumab0Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 100 mg + Avelumab5Not reportedNot reportedNot reportedNot reported
Combination C Phase 1b: PD 0360324 150 mg + Avelumab5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    ADA ever-positive -Avelumab
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
    title
    ADA ever-positive -PD 0360324
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      6
    units
    Participants
description
ADA ever-positive was defined as at least one positive ADA result at any time point.
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
COUNT_OF_PARTICIPANTS
population Description
The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10
title
Number of Participants With Positive ADA Levels For Combination C
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice