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NCT03277352 · OUTCOME

Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST

INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies · Source last updated 2021-07-22

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

Measure
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months

What was measured

Defined as time from first report of SD or better until disease progression or death from any cause.

Analysis population: The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.

Groups in this outcome

INCAGN01876 + Pembrolizumab + Epacadostat

INCAGN01876 in combination with pembrolizumab and epacadostat

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

Analysis denominator · Participants

GroupSource count
INCAGN01876 + Pembrolizumab + Epacadostat10

Reported measurements

mRECIST
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
INCAGN01876 + Pembrolizumab + EpacadostatNANot reported525NAThe median duration of response is not estimable if less than half of the participants had an event (progression or death).
RECIST
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
INCAGN01876 + Pembrolizumab + Epacadostat525Not reported92NAThe number of responders is not enough to estimate a standard error for the confidence interval.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The median duration of response is not estimable if less than half of the participants had an event (progression or death).
        group Id
        OG000
        lower Limit
        525
        upper Limit
        NA
        value
        NA
    title
    mRECIST
  2. categories
    1. measurements
      1. comment
        The number of responders is not enough to estimate a standard error for the confidence interval.
        group Id
        OG000
        lower Limit
        92
        upper Limit
        NA
        value
        525
    title
    RECIST
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Defined as time from first report of SD or better until disease progression or death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    INCAGN01876 in combination with pembrolizumab and epacadostat
    id
    OG000
    title
    INCAGN01876 + Pembrolizumab + Epacadostat
param Type
MEDIAN
population Description
The FAS includes all participants enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
reporting Status
POSTED
time Frame
Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
title
Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice