Skip to content
TriangleGet started
← Full study record

NCT02460198 · OUTCOME

Duration of Response (DOR) Per RECIST 1.1 as Assessed by the Central Imaging Vendor

Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164) · Source last updated 2023-07-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
Up to approximately 66 months

What was measured

For participants who demonstrated a CR or PR, duration of response was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. Duration of Response was based on Independent radiologist review (IRC) using RECIST 1.1 and was summarized by Kaplan-Meier (KM) methods for censored data. Nonresponders were excluded from the analysis of DOR.

Analysis population: The analysis population consisted of all participants who received at least one dose of study treatment and demonstrated a CR or PR.

Groups in this outcome

Cohort A - Pembrolizumab 200 mg

Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).

Cohort B - Pembrolizumab 200 mg

Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).

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

Analysis denominator · Participants

GroupSource count
Cohort A - Pembrolizumab 200 mg20
Cohort B - Pembrolizumab 200 mg22

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort A - Pembrolizumab 200 mgNANot reported6.2NANA = Median DOR and DOR upper limit were not reached by the time of last disease assessment.
Cohort B - Pembrolizumab 200 mgNANot reported4.4NANA = Median DOR and DOR upper limit were not reached by the time of last disease assessment.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA = Median DOR and DOR upper limit were not reached by the time of last disease assessment.
        group Id
        OG000
        lower Limit
        6.2
        upper Limit
        NA
        value
        NA
      2. comment
        NA = Median DOR and DOR upper limit were not reached by the time of last disease assessment.
        group Id
        OG001
        lower Limit
        4.4
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      22
    units
    Participants
description
For participants who demonstrated a CR or PR, duration of response was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. Duration of Response was based on Independent radiologist review (IRC) using RECIST 1.1 and was summarized by Kaplan-Meier (KM) methods for censored data. Nonresponders were excluded from the analysis of DOR.
dispersion Type
Full Range
groups
  1. description
    Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
    id
    OG000
    title
    Cohort A - Pembrolizumab 200 mg
  2. description
    Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
    id
    OG001
    title
    Cohort B - Pembrolizumab 200 mg
param Type
MEDIAN
population Description
The analysis population consisted of all participants who received at least one dose of study treatment and demonstrated a CR or PR.
reporting Status
POSTED
time Frame
Up to approximately 66 months
title
Duration of Response (DOR) Per RECIST 1.1 as Assessed by the Central Imaging Vendor
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice