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NCT02573259 · OUTCOME

Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to end of treatment in Part 1 (maximum of 1606 days)

What was measured

Number of participants achieving confirmed OR based on irRECIST in Part 1. OR = irCR + irPR. Overall immune related complete response (irCR) was defined as complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. Overall immune related partial response (irPR) was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases \>=30%.

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)

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])2
Part 1: PF-06801591 1 mg/kg (IV)7
Part 1: PF-06801591 3 mg/kg (IV)8
Part 1: PF-06801591 10 mg/kg (IV)7
Part 1: PF-06801591 300 mg (Subcutaneously [SC])15

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 1 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 3 mg/kg (IV)1Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 10 mg/kg (IV)2Not reportedNot reportedNot reportedNot reported
Part 1: PF-06801591 300 mg (Subcutaneously [SC])1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      15
    units
    Participants
description
Number of participants achieving confirmed OR based on irRECIST in Part 1. OR = irCR + irPR. Overall immune related complete response (irCR) was defined as complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \<10 mm. Overall immune related partial response (irPR) was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases \>=30%.
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])
param Type
COUNT_OF_PARTICIPANTS
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 1 (maximum of 1606 days)
title
Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice