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NCT02721732 · OUTCOME

Immune-related Progression-free Survival (PFS) Using irRECIST

Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic · Source last updated 2026-07-17

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks.

What was measured

Immune-related PFS was defined as the time from administration of the first dose to the first documented disease progression according to irRECIST or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.

Analysis population: All patients who have received at least 1 dose of study medication with at least one adequate on-study tumor assessment were included in the efficacy analysis. If a patient discontinued the study before the first radiological assessment due to progression of disease, either radiological or clinical, they were considered evaluable and were included in the efficacy analysis. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis.

Groups in this outcome

All Patients Who Received at Least One Dose of the Drug

MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle

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

Analysis denominator · Participants

GroupSource count
All Patients Who Received at Least One Dose of the Drug146

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Patients Who Received at Least One Dose of the Drug2.3Not reported23.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        3.6
        value
        2.3
denoms
  1. counts
    1. group Id
      OG000
      value
      146
    units
    Participants
description
Immune-related PFS was defined as the time from administration of the first dose to the first documented disease progression according to irRECIST or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.
dispersion Type
95% Confidence Interval
groups
  1. description
    MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
    id
    OG000
    title
    All Patients Who Received at Least One Dose of the Drug
param Type
MEDIAN
population Description
All patients who have received at least 1 dose of study medication with at least one adequate on-study tumor assessment were included in the efficacy analysis. If a patient discontinued the study before the first radiological assessment due to progression of disease, either radiological or clinical, they were considered evaluable and were included in the efficacy analysis. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis.
reporting Status
POSTED
time Frame
Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks.
title
Immune-related Progression-free Survival (PFS) Using irRECIST
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice