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NCT01876511 · OUTCOME

Objective Response Rate 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
28 months

What was measured

For Cohorts A and C: Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions.

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 Cancer54Not reported3769Not reported
Cohort C: MSI Positive Non-Colorectal Cancer55Not reported4070Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37
        upper Limit
        69
        value
        54
      2. group Id
        OG001
        lower Limit
        40
        upper Limit
        70
        value
        55
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      47
    units
    Participants
description
For Cohorts A and C: Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions.
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
28 months
title
Objective Response Rate 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