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NCT01876511 · OUTCOME

Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive Non-colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2

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 Cohort C: irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 20 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.

Analysis population: It was a pre-specified objective to complete this objective in Cohort C only. Per protocol during stages 1 and 2, the study enrollment goal was 21 for Cohort C. Additional subjects for this study were enrolled during the second expansion portion of this protocol.

Groups in this outcome

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 C: MSI Positive Non-Colorectal Cancer21

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort C: MSI Positive Non-Colorectal Cancer67Not reported4990Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49
        upper Limit
        90
        value
        67
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    units
    Participants
description
For Cohort C: irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 20 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. 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 C: MSI Positive Non-Colorectal Cancer
param Type
NUMBER
population Description
It was a pre-specified objective to complete this objective in Cohort C only. Per protocol during stages 1 and 2, the study enrollment goal was 21 for Cohort C. Additional subjects for this study were enrolled during the second expansion portion of this protocol.
reporting Status
POSTED
time Frame
20 weeks
title
Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive Non-colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2
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