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NCT02554812 · OUTCOME

DR for 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
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)

What was measured

DR as assessed by investigator according to RECIST v1.1, was defined as the time from date of first documentation of objective response (CR or PR) to date of PD or death due to any cause, or data censoring date, whichever occurred first. CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) reduced in short axis to \<10 mm. PR: \>= 30% decrease in sum of diameter of target lesions taking as reference baseline sum diameters. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study treatment, with absolute increase of at least 5 mm or appearance of \>=1 new lesions. DR data was censored on the date of last adequate tumor assessment for participants without an event (CR, PR, PD or death), for participants who start new anti-cancer treatment prior to DR assessment, for participants with DR assessment after \>=2 missing tumor assessments.

Analysis population: Full analysis set included all enrolled participants who received at least one dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

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 + Avelumab0
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab0
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab0
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab2
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab2

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab5.6Not reported3.77.4Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab23.5Not reported20.926.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG003
        lower Limit
        3.7
        upper Limit
        7.4
        value
        5.6
      2. group Id
        OG004
        lower Limit
        20.9
        upper Limit
        26.0
        value
        23.5
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      2
    units
    Participants
description
DR as assessed by investigator according to RECIST v1.1, was defined as the time from date of first documentation of objective response (CR or PR) to date of PD or death due to any cause, or data censoring date, whichever occurred first. CR: disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) reduced in short axis to \<10 mm. PR: \>= 30% decrease in sum of diameter of target lesions taking as reference baseline sum diameters. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study treatment, with absolute increase of at least 5 mm or appearance of \>=1 new lesions. DR data was censored on the date of last adequate tumor assessment for participants without an event (CR, PR, PD or death), for participants who start new anti-cancer treatment prior to DR assessment, for participants with DR assessment after \>=2 missing tumor assessments.
dispersion Type
Full Range
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
MEDIAN
population Description
Full analysis set included all enrolled participants who received at least one dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)
title
DR for Combination B
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice