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NCT02178722 · OUTCOME

Phase 2: Duration of Response (DOR)

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

Duration of response is the time from the first overall response contributing to an objective response (complete or partial response) for DLBCL to the date of death or the date of first overall response of progressive diseasemeasured (by irRECIST for solid tumors or the Lugano Classification, whichever is earliest.

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 and those who responded.

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 Q3W105

Reported measurements

Hepatocellular Carcinoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W4
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reported2.04NAinsufficient number of participants with events
Triple Negative Breast Cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W4
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reported0.92NAinsufficient number of participants with events
Immune Checkpoint-naïve Melanoma

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 Q3WNANot reported26.35NAinsufficient number of participants with events
NSCLC high positive (PD-L1 TPS ≥ 50%)

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W4
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W12.44Not reported2.1016.53Not reported
NSCLC low/negative or indeterminate (PD-L1 TPS < 50% or indeterminate)

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W2
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W11.93Not reported8.9014.95Not reported
NSCLC (TPS 0%)

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W4
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reported7.43NAinsufficient number of participants with events
NSCLC Unknown

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W5
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W10.84Not reported4.14NAinsufficient number of participants with events
Renal Cell Carcinoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W12
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W16.95Not reported12.58NAinsufficient 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 Q3W12
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W11.33Not reported3.9431.74Not reported
Transitional Cell Carcinoma of the GU Tract

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 Q3WNANot reported10.64NAinsufficient number of participants with events
Ovarian Cancer

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 reported5.75NAinsufficient number of participants with events
Gastric Cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W6
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3WNANot reported0.46NAinsufficient number of participants with events
MSI high Colorectal 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 reported4.17NAinsufficient number of participants with events
DLBCL

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W5
Values in Months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W3.66Not reported0.72NAinsufficient 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
        2.04
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Hepatocellular Carcinoma
  2. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        0.92
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Triple Negative Breast Cancer
  3. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        26.35
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Immune Checkpoint-naïve Melanoma
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.10
        upper Limit
        16.53
        value
        12.44
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    NSCLC high positive (PD-L1 TPS ≥ 50%)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.90
        upper Limit
        14.95
        value
        11.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    NSCLC low/negative or indeterminate (PD-L1 TPS < 50% or indeterminate)
  6. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        7.43
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    NSCLC (TPS 0%)
  7. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        4.14
        upper Limit
        NA
        value
        10.84
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    NSCLC Unknown
  8. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        12.58
        upper Limit
        NA
        value
        16.95
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Renal Cell Carcinoma
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.94
        upper Limit
        31.74
        value
        11.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Squamous Cell Carcinoma of the Head and Neck
  10. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        10.64
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Transitional Cell Carcinoma of the GU Tract
  11. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        5.75
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Ovarian Cancer
  12. categories
    1. measurements
      1. comment
        insufficient number of participants with events
        group Id
        OG000
        lower Limit
        0.46
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Gastric Cancer
denoms
  1. counts
    1. group Id
      OG000
      value
      105
    units
    Participants
description
Duration of response is the time from the first overall response contributing to an objective response (complete or partial response) for DLBCL to the date of death or the date of first overall response of progressive diseasemeasured (by irRECIST for solid tumors or the Lugano Classification, whichever is earliest.
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 and those who responded.
reporting Status
POSTED
time Frame
Up to 54 months
title
Phase 2: Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice