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NCT02178722 · OUTCOME

Phase 2: Duration of Disease Control

Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers · Source last updated 2022-02-14

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
90% Confidence Interval
Time frame
Up to 54 months

What was measured

The duration of disease control is the time from the treatment start date to the first objective response of PD (by irRECIST v1.1 or Lugano Classification), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or better.

Analysis population: The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type. The median time and the 90% CI were estimated using Kaplan-Meier method.

Groups in this outcome

Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W

Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.

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

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W191

Reported measurements

Hepatocellular Carcinoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W15
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W10.38Not reported5.49NAinsufficient number of participants with events
Triple Negative Breast Cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W11
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W11.47Not reported4.0112.65Not reported
Immune Checkpoint-naïve Melanoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W31
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W30.29Not reported25.03NAinsufficient number of participants with events
Relapsed Melanoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W1
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W4.21Not reportedNANAinsufficient number of participants with events
NSCLC Total

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W30
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W14.42Not reported8.5119.45Not reported
Renal Cell Carcinoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W22
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W13.39Not reported5.1318.86Not reported
Squamous Cell Carcinoma of the Head and Neck

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W20
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W9.18Not reported6.2413.34Not reported
Transitional Cell Carcinoma of the GU Tract

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W21
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W15.36Not reported8.4122.74Not reported
Ovarian Cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W14
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W5.08Not reported3.297.79Not reported
Gastric Cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W7
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reported2.56NAinsufficient number of participants with events
MSI high Colorectal Cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W10
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reported6.11NAinsufficient number of participants with events
DLBCL

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W9
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W7.29Not reported4.0110.91Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        5.49
        upper Limit
        NA
        value
        10.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Hepatocellular Carcinoma
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.01
        upper Limit
        12.65
        value
        11.47
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Triple Negative Breast Cancer
  3. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        25.03
        upper Limit
        NA
        value
        30.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Immune Checkpoint-naïve Melanoma
  4. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        4.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Relapsed Melanoma
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.51
        upper Limit
        19.45
        value
        14.42
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      units
      Participants
    title
    NSCLC Total
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.13
        upper Limit
        18.86
        value
        13.39
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Renal Cell Carcinoma
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.24
        upper Limit
        13.34
        value
        9.18
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Squamous Cell Carcinoma of the Head and Neck
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.41
        upper Limit
        22.74
        value
        15.36
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      units
      Participants
    title
    Transitional Cell Carcinoma of the GU Tract
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.29
        upper Limit
        7.79
        value
        5.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Ovarian Cancer
  10. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        2.56
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Gastric Cancer
  11. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        6.11
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    MSI high Colorectal Cancer
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.01
        upper Limit
        10.91
        value
        7.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    DLBCL
denoms
  1. counts
    1. group Id
      OG000
      value
      191
    units
    Participants
description
The duration of disease control is the time from the treatment start date to the first objective response of PD (by irRECIST v1.1 or Lugano Classification), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or better.
dispersion Type
90% Confidence Interval
groups
  1. description
    Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 200 mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    OG000
    title
    Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W
param Type
MEDIAN
population Description
The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab). Number analyzed indicated participants analyzed in the respective tumor type. The median time and the 90% CI were estimated using Kaplan-Meier method.
reporting Status
POSTED
time Frame
Up to 54 months
title
Phase 2: Duration of Disease Control
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice