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NCT02178722 · OUTCOME

Phase 2: Progression Free Survival (PFS)

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

Progression-free survival is defined as number of days from the first day of taking study drug to the earlier of death or disease progression by irRECIST v1.1 for select solid tumors and modified Lugano Classification for DLBCL.

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.

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 Q3W5.49Not reported2.6910.28Not reported
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 Q3W1.97Not reported1.872.92Not 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 Q3W16.69Not reported6.24NAinsufficient 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 Q3W1.69Not reported1.252.14Not reported
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 Q3W2.60Not reported2.144.21Not reported
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 Q3W4.09Not reported2.147.36Not 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 Q3W4.50Not reported2.336.24Not reported
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 Q3W4.37Not reported2.307.79Not 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 Q3W4.40Not reported2.148.90Not reported
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 Q3W2.10Not reported1.972.83Not 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 Q3W1.97Not reported1.412.07Not 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 Q3W6.11Not reported2.07NAinsufficient 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 Q3W2.63Not reported1.874.01Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.69
        upper Limit
        10.28
        value
        5.49
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Hepatocellular Carcinoma
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.87
        upper Limit
        2.92
        value
        1.97
    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
        6.24
        upper Limit
        NA
        value
        16.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      units
      Participants
    title
    Immune Checkpoint-naïve Melanoma
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.25
        upper Limit
        2.14
        value
        1.69
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Primary Refractory Melanoma
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.14
        upper Limit
        4.21
        value
        2.60
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Relapsed Melanoma
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.14
        upper Limit
        7.36
        value
        4.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    NSCLC
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.33
        upper Limit
        6.24
        value
        4.50
    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
        2.30
        upper Limit
        7.79
        value
        4.37
    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. group Id
        OG000
        lower Limit
        2.14
        upper Limit
        8.90
        value
        4.40
    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
        1.97
        upper Limit
        2.83
        value
        2.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    Ovarian Cancer
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.41
        upper Limit
        2.07
        value
        1.97
    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
        2.07
        upper Limit
        NA
        value
        6.11
    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
Progression-free survival is defined as number of days from the first day of taking study drug to the earlier of death or disease progression by irRECIST v1.1 for select solid tumors and modified Lugano Classification for DLBCL.
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.
reporting Status
POSTED
time Frame
Up to 54 months
title
Phase 2: Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice