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NCT01876511 · OUTCOME

Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C) · Source last updated 2020-02-06

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
20 weeks

What was measured

For Cohorts A and C: PFS is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 20 weeks. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.

Analysis population: It was a pre-specified objective to complete this objective in Cohort A and C only.

Groups in this outcome

Cohort A: MSI Positive Colorectal Cancer

MK-3475: MK-3475 10 mg/kg every 14 days

Cohort C: MSI Positive Non-Colorectal Cancer

MK-3475: MK-3475 10 mg/kg every 14 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
Cohort A: MSI Positive Colorectal Cancer41
Cohort C: MSI Positive Non-Colorectal Cancer47

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A: MSI Positive Colorectal Cancer75Not reported6390Not reported
Cohort C: MSI Positive Non-Colorectal Cancer68Not reported5683Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        63
        upper Limit
        90
        value
        75
      2. group Id
        OG001
        lower Limit
        56
        upper Limit
        83
        value
        68
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      47
    units
    Participants
description
For Cohorts A and C: PFS is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 20 weeks. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
dispersion Type
95% Confidence Interval
groups
  1. description
    MK-3475: MK-3475 10 mg/kg every 14 days
    id
    OG000
    title
    Cohort A: MSI Positive Colorectal Cancer
  2. description
    MK-3475: MK-3475 10 mg/kg every 14 days
    id
    OG001
    title
    Cohort C: MSI Positive Non-Colorectal Cancer
param Type
NUMBER
population Description
It was a pre-specified objective to complete this objective in Cohort A and C only.
reporting Status
POSTED
time Frame
20 weeks
title
Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
type
PRIMARY
unit Of Measure
percentage of participants

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

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