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NCT02573259 · OUTCOME

Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2

A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors · Source last updated 2021-12-13

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
Baseline up to end of treatment (maximum of 1606 days)

What was measured

DOSD was analyzed by the Kaplan-Meier approach for each tumor type. Stable disease (SD) was defined as not qualifying for complete response (CR), partial response (PR), or progression. All target lesions must have been assessed. Stable could follow PR only in the rare case that the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer held. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). All target lesions must have been assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.

Analysis population: Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.

Groups in this outcome

Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])

Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)

Part 1: PF-06801591 1 mg/kg (IV)

Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)

Part 1: PF-06801591 3 mg/kg (IV)

Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)

Part 1: PF-06801591 10 mg/kg (IV)

Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)

Part 1: PF-06801591 300 mg (Subcutaneously [SC])

Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)

Part 2: PF-06801591 300 mg (SC) for NSCLC

Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)

Part 2: PF-06801591 300 mg (SC) for UC

Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)

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

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1
Part 1: PF-06801591 1 mg/kg (IV)2
Part 1: PF-06801591 3 mg/kg (IV)3
Part 1: PF-06801591 10 mg/kg (IV)2
Part 1: PF-06801591 300 mg (Subcutaneously [SC])5
Part 2: PF-06801591 300 mg (SC) for NSCLC24
Part 2: PF-06801591 300 mg (SC) for UC12

Reported measurements

RECIST v1.1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedNot estimable for n\<2.
Part 1: PF-06801591 1 mg/kg (IV)NANot reported4.6NANot estimable for n\<2.
Part 1: PF-06801591 3 mg/kg (IV)24.3Not reported13.834.9Not reported
Part 1: PF-06801591 10 mg/kg (IV)5.7Not reported2.58.8Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])6.0Not reported3.87.3Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC6.5Not reported3.710.1Not reported
Part 2: PF-06801591 300 mg (SC) for UC8.5Not reported3.7NANot estimable.
irRECIST
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])NANot reportedNot reportedNot reportedNot estimable for n\<2.
Part 1: PF-06801591 1 mg/kg (IV)NANot reported4.6NANot estimable for n\<2.
Part 1: PF-06801591 3 mg/kg (IV)29.0Not reported20.037.9Not reported
Part 1: PF-06801591 10 mg/kg (IV)5.7Not reported2.58.8Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])13.7Not reported3.313.7Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC7.5Not reported5.418.4Not reported
Part 2: PF-06801591 300 mg (SC) for UC14.5Not reported3.7NANot estimable.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable for n\<2.
        group Id
        OG000
        value
        NA
      2. comment
        Not estimable for n\<2.
        group Id
        OG001
        lower Limit
        4.6
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        13.8
        upper Limit
        34.9
        value
        24.3
      4. group Id
        OG003
        lower Limit
        2.5
        upper Limit
        8.8
        value
        5.7
      5. group Id
        OG004
        lower Limit
        3.8
        upper Limit
        7.3
        value
        6.0
      6. group Id
        OG005
        lower Limit
        3.7
        upper Limit
        10.1
        value
        6.5
      7. comment
        Not estimable.
        group Id
        OG006
        lower Limit
        3.7
        upper Limit
        NA
        value
        8.5
    title
    RECIST v1.1
  2. categories
    1. measurements
      1. comment
        Not estimable for n\<2.
        group Id
        OG000
        value
        NA
      2. comment
        Not estimable for n\<2.
        group Id
        OG001
        lower Limit
        4.6
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        20.0
        upper Limit
        37.9
        value
        29.0
      4. group Id
        OG003
        lower Limit
        2.5
        upper Limit
        8.8
        value
        5.7
      5. group Id
        OG004
        lower Limit
        3.3
        upper Limit
        13.7
        value
        13.7
      6. group Id
        OG005
        lower Limit
        5.4
        upper Limit
        18.4
        value
        7.5
      7. comment
        Not estimable.
        group Id
        OG006
        lower Limit
        3.7
        upper Limit
        NA
        value
        14.5
    title
    irRECIST
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      5
    6. group Id
      OG005
      value
      24
    7. group Id
      OG006
      value
      12
    units
    Participants
description
DOSD was analyzed by the Kaplan-Meier approach for each tumor type. Stable disease (SD) was defined as not qualifying for complete response (CR), partial response (PR), or progression. All target lesions must have been assessed. Stable could follow PR only in the rare case that the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer held. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \< 10 mm). All target lesions must have been assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
    id
    OG000
    title
    Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
  2. description
    Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
    id
    OG001
    title
    Part 1: PF-06801591 1 mg/kg (IV)
  3. description
    Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
    id
    OG002
    title
    Part 1: PF-06801591 3 mg/kg (IV)
  4. description
    Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
    id
    OG003
    title
    Part 1: PF-06801591 10 mg/kg (IV)
  5. description
    Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
    id
    OG004
    title
    Part 1: PF-06801591 300 mg (Subcutaneously [SC])
  6. description
    Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
    id
    OG005
    title
    Part 2: PF-06801591 300 mg (SC) for NSCLC
  7. description
    Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
    id
    OG006
    title
    Part 2: PF-06801591 300 mg (SC) for UC
param Type
MEDIAN
population Description
Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.
reporting Status
POSTED
time Frame
Baseline up to end of treatment (maximum of 1606 days)
title
Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice