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NCT02554812 · OUTCOME

Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B

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
Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 3.5 years)

What was measured

TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AEs was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per NCI CTCAE v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Analysis population: The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.

Groups in this outcome

Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab

During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab

During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab

During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab

During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab

During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

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 B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab12
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab12
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab8
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab14
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab25

Reported measurements

TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab12Not reportedNot reportedNot reportedNot reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab12Not reportedNot reportedNot reportedNot reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab8Not reportedNot reportedNot reportedNot reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab14Not reportedNot reportedNot reportedNot reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab25Not reportedNot reportedNot reportedNot reported
Grade >=3 TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab4Not reportedNot reportedNot reportedNot reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab6Not reportedNot reportedNot reportedNot reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab4Not reportedNot reportedNot reportedNot reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab7Not reportedNot reportedNot reportedNot reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab13Not reportedNot reportedNot reportedNot reported
Serious TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab3Not reportedNot reportedNot reportedNot reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab4Not reportedNot reportedNot reportedNot reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab1Not reportedNot reportedNot reportedNot reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab3Not reportedNot reportedNot reportedNot reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab10Not reportedNot reportedNot reportedNot reported
Treatment related TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab7Not reportedNot reportedNot reportedNot reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab7Not reportedNot reportedNot reportedNot reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab7Not reportedNot reportedNot reportedNot reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab12Not reportedNot reportedNot reportedNot reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        14
      5. group Id
        OG004
        value
        25
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        13
    title
    Grade >=3 TEAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        10
    title
    Serious TEAEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        14
    title
    Treatment related TEAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      14
    5. group Id
      OG004
      value
      25
    units
    Participants
description
TEAEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period. Treatment-related AEs was any untoward medical occurrence attributed to study drug in a participant who received study drug. Per NCI CTCAE v4.03: Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment; Grade 4 (Life-threatening) events caused participant to be in imminent danger of death; Grade 5 (Death) events=death related to an AE. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in participant hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
groups
  1. description
    During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
    id
    OG000
    title
    Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
  2. description
    During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
    id
    OG001
    title
    Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
  3. description
    During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
    id
    OG002
    title
    Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
  4. description
    During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
    id
    OG003
    title
    Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
  5. description
    During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
    id
    OG004
    title
    Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population included all participants who received at least one dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than one study treatment, the participant were classified according to the first treatment received.
reporting Status
POSTED
time Frame
Baseline up to 30 days after last dose of study treatment or the day before start day of new anti-cancer therapy (maximum of 3.5 years)
title
Number of Participants With TEAEs, Grade >= 3 TEAEs, Serious TEAEs and Treatment Related TEAEs: Combination B
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice