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NCT02573259 · OUTCOME

Duration of Response (DOR) 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

DOR was defined as the time from start date (which was the date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group.

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. DOR was only applicable to those participants with an objective response.

Groups in this outcome

Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [IV])

This was a combined group of PF-06801591 0.5, 1, 3, and 10 mg/kg (IV) in Part 1. Participants received PF-06801591 0.5, 1, 3, or 10 mg/kg IV every 3 weeks for 21-day cycles. (up to a maximum of 233 weeks).

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 0.5-10 mg/kg (Intravenously [IV])6
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1
Part 2: PF-06801591 300 mg (SC) for NSCLC13
Part 2: PF-06801591 300 mg (SC) for UC8

Reported measurements

RECIST v1.1

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [IV])6
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1
Part 2: PF-06801591 300 mg (SC) for NSCLC11
Part 2: PF-06801591 300 mg (SC) for UC7
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [IV])9.7Not reported3.7NANot estimable.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedNot estimable.
Part 2: PF-06801591 300 mg (SC) for NSCLC21.8Not reported5.8NANot estimable.
Part 2: PF-06801591 300 mg (SC) for UC13.9Not reported3.8NANot estimable.
irRECIST

Analysis denominator · Participants

GroupSource count
Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [IV])6
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1
Part 2: PF-06801591 300 mg (SC) for NSCLC13
Part 2: PF-06801591 300 mg (SC) for UC8
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [IV])13.0Not reported4.1NANot estimable.
Part 1: PF-06801591 300 mg (Subcutaneously [SC])NANot reportedNot reportedNot reportedNot estimable.
Part 2: PF-06801591 300 mg (SC) for NSCLC22.1Not reported6.8NANot estimable.
Part 2: PF-06801591 300 mg (SC) for UCNANot reported4.6NANot estimable.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable.
        group Id
        OG000
        lower Limit
        3.7
        upper Limit
        NA
        value
        9.7
      2. comment
        Not estimable.
        group Id
        OG001
        value
        NA
      3. comment
        Not estimable.
        group Id
        OG002
        lower Limit
        5.8
        upper Limit
        NA
        value
        21.8
      4. comment
        Not estimable.
        group Id
        OG003
        lower Limit
        3.8
        upper Limit
        NA
        value
        13.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        7
      units
      Participants
    title
    RECIST v1.1
  2. categories
    1. measurements
      1. comment
        Not estimable.
        group Id
        OG000
        lower Limit
        4.1
        upper Limit
        NA
        value
        13.0
      2. comment
        Not estimable.
        group Id
        OG001
        value
        NA
      3. comment
        Not estimable.
        group Id
        OG002
        lower Limit
        6.8
        upper Limit
        NA
        value
        22.1
      4. comment
        Not estimable.
        group Id
        OG003
        lower Limit
        4.6
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        8
      units
      Participants
    title
    irRECIST
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      8
    units
    Participants
description
DOR was defined as the time from start date (which was the date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group.
dispersion Type
95% Confidence Interval
groups
  1. description
    This was a combined group of PF-06801591 0.5, 1, 3, and 10 mg/kg (IV) in Part 1. Participants received PF-06801591 0.5, 1, 3, or 10 mg/kg IV every 3 weeks for 21-day cycles. (up to a maximum of 233 weeks).
    id
    OG000
    title
    Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [IV])
  2. description
    Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
    id
    OG001
    title
    Part 1: PF-06801591 300 mg (Subcutaneously [SC])
  3. description
    Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
    id
    OG002
    title
    Part 2: PF-06801591 300 mg (SC) for NSCLC
  4. description
    Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
    id
    OG003
    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. DOR was only applicable to those participants with an objective response.
reporting Status
POSTED
time Frame
Baseline up to end of treatment (maximum of 1606 days)
title
Duration of Response (DOR) 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