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NCT02573259 · OUTCOME

Objective Response Rate (ORR) Based on RECIST Version 1.1 - 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
NUMBER
Unit
Percentage
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to end of treatment in Part 2 (maximum of 851 days)

What was measured

ORR was defined as percentage of participants with confirmed objective response (OR) of complete response (CR) and partial response (PR) based on RECIST version 1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 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 be 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 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 2: PF-06801591 300 mg (SC) for NSCLC67
Part 2: PF-06801591 300 mg (SC) for UC38

Reported measurements

Source class 1
Values in Percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: PF-06801591 300 mg (SC) for NSCLC16.4Not reported8.527.5Not reported
Part 2: PF-06801591 300 mg (SC) for UC18.4Not reported7.734.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.5
        upper Limit
        27.5
        value
        16.4
      2. group Id
        OG001
        lower Limit
        7.7
        upper Limit
        34.3
        value
        18.4
denoms
  1. counts
    1. group Id
      OG000
      value
      67
    2. group Id
      OG001
      value
      38
    units
    Participants
description
ORR was defined as percentage of participants with confirmed objective response (OR) of complete response (CR) and partial response (PR) based on RECIST version 1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \< 10 mm). All target lesions must be assessed. PR was defined as \>= 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 be assessed.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
    id
    OG000
    title
    Part 2: PF-06801591 300 mg (SC) for NSCLC
  2. description
    Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
    id
    OG001
    title
    Part 2: PF-06801591 300 mg (SC) for UC
param Type
NUMBER
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 in Part 2 (maximum of 851 days)
title
Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2
type
PRIMARY
unit Of Measure
Percentage

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Preserved source evidence · Not medical advice