Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02573259 · OUTCOME

Progression-Free Survival (PFS) 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

PFS was defined as the time from initiation of study intervention to first documentation of tumor progression or to death due to any cause, whichever occurred first. PFS was analyzed by the Kaplan-Meier approach for each tumor type. 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.

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])24
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15
Part 2: PF-06801591 300 mg (SC) for NSCLC67
Part 2: PF-06801591 300 mg (SC) for UC38

Reported measurements

RECIST v1.1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [IV])4.7Not reported1.48.3Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])3.0Not reported1.66.0Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC3.7Not reported1.95.5Not reported
Part 2: PF-06801591 300 mg (SC) for UC2.9Not reported1.93.8Not reported
irRECIST
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [IV])4.9Not reported1.413.8Not reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])4.5Not reported1.913.7Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC5.5Not reported2.88.2Not reported
Part 2: PF-06801591 300 mg (SC) for UC3.8Not reported2.014.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        8.3
        value
        4.7
      2. group Id
        OG001
        lower Limit
        1.6
        upper Limit
        6.0
        value
        3.0
      3. group Id
        OG002
        lower Limit
        1.9
        upper Limit
        5.5
        value
        3.7
      4. group Id
        OG003
        lower Limit
        1.9
        upper Limit
        3.8
        value
        2.9
    title
    RECIST v1.1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        13.8
        value
        4.9
      2. group Id
        OG001
        lower Limit
        1.9
        upper Limit
        13.7
        value
        4.5
      3. group Id
        OG002
        lower Limit
        2.8
        upper Limit
        8.2
        value
        5.5
      4. group Id
        OG003
        lower Limit
        2.0
        upper Limit
        14.5
        value
        3.8
    title
    irRECIST
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      67
    4. group Id
      OG003
      value
      38
    units
    Participants
description
PFS was defined as the time from initiation of study intervention to first documentation of tumor progression or to death due to any cause, whichever occurred first. PFS was analyzed by the Kaplan-Meier approach for each tumor type. 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.
reporting Status
POSTED
time Frame
Baseline up to end of treatment (maximum of 1606 days)
title
Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice