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NCT02178722 · OUTCOME

Phase 2: Overall Survival (OS)

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

Overall survival is determined from the date of first dose until death due to any cause.

Analysis population: The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug. 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 Q3W382

Reported measurements

Hepatocellular Carcinoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W24
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reported8.94NAinsufficient number of participants with events
Triple Negative Breast Cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W36
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W5.16Not reported4.607.46Not reported
Immune Checkpoint-naïve Melanoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W43
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reportedNANAinsufficient number of participants with events
Primary Refractory Melanoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W3
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reportedNANAinsufficient number of participants with events
Relapsed Melanoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W3
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reported2.60NAinsufficient number of participants with events
NSCLC

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W58
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W14.62Not reported9.7224.38Not reported
Renal Cell Carcinoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W37
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reported18.40NAinsufficient number of participants with events
Squamous Cell Carcinoma of the Head and Neck

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W36
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W8.34Not reported4.3715.41Not reported
Transitional Cell Carcinoma of the GU Tract

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W36
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W13.44Not reported8.41NAinsufficient number of participants with events
Ovarian Cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W37
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W13.11Not reported8.3425.92Not reported
Gastric Cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W27
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W4.04Not reported1.9715.84Not reported
MSI high Colorectal Cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W16
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reported8.15NAinsufficient number of participants with events
DLBCL

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W26
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W11.79Not reported4.37NAinsufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        8.94
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Hepatocellular Carcinoma
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.60
        upper Limit
        7.46
        value
        5.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Triple Negative Breast Cancer
  3. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      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
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Primary Refractory Melanoma
  5. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        2.60
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Relapsed Melanoma
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.72
        upper Limit
        24.38
        value
        14.62
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    NSCLC
  7. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        18.40
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    Renal Cell Carcinoma
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.37
        upper Limit
        15.41
        value
        8.34
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Squamous Cell Carcinoma of the Head and Neck
  9. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        8.41
        upper Limit
        NA
        value
        13.44
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Transitional Cell Carcinoma of the GU Tract
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.34
        upper Limit
        25.92
        value
        13.11
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    Ovarian Cancer
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.97
        upper Limit
        15.84
        value
        4.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    Gastric Cancer
  12. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        8.15
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    MSI high Colorectal Cancer
denoms
  1. counts
    1. group Id
      OG000
      value
      382
    units
    Participants
description
Overall survival is determined from the date of first dose until death due to any cause.
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. 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: Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice