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NCT02178722 · OUTCOME

Phase 2: Objective Response Rate (ORR)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Approximately 54 months

What was measured

ORR was percentage of participants with best overall response \[complete response (CR) or partial response (PR)\], per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

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 in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).

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

Triple negative breast cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W36
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W11.1Not reportedNot reportedNot reportedNot reported
Microsatellite-instability high colorectal cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W16
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W43.8Not reportedNot reportedNot reportedNot reported
Gastric cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W27
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W22.2Not reportedNot reportedNot reportedNot reported
Hepatocellular carcinoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W24
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W16.7Not reportedNot reportedNot reportedNot reported
Melanoma - immune checkpoint-naïve

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W43
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W60.5Not reportedNot reportedNot reportedNot reported
Non-small cell lung cancer (NSCLC) (tumor proportion score (TPS) < 50% or indeterminate)

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W13
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W30.8Not reportedNot reportedNot reportedNot reported
NSCLC programmed cell death ligand (PD-L1) low negative (TPS < 50%)

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W45
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W24.4Not reportedNot reportedNot reportedNot reported
Ovarian cancer

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W37
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W8.1Not reportedNot reportedNot reportedNot reported
Renal cell carcinoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W37
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W32.4Not reportedNot reportedNot reportedNot reported
Squamous cell carcinoma of the head and neck

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W36
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W33.3Not reportedNot reportedNot reportedNot reported
Transitional carcinoma of the genitourinary (GU) tract

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W36
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W30.6Not reportedNot reportedNot reportedNot reported
Diffuse large B-cell lymphoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W26
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W19.2Not reportedNot reportedNot reportedNot reported
Primary Refractory Melanoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W3
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W0.0Not reportedNot reportedNot reportedNot reported
Relapsed Melanoma

Analysis denominator · Participants

GroupSource count
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W3
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Triple negative breast cancer
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        43.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Microsatellite-instability high colorectal cancer
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        22.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    Gastric cancer
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        16.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Hepatocellular carcinoma
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        60.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      units
      Participants
    title
    Melanoma - immune checkpoint-naïve
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        30.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Non-small cell lung cancer (NSCLC) (tumor proportion score (TPS) < 50% or indeterminate)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        24.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    NSCLC programmed cell death ligand (PD-L1) low negative (TPS < 50%)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        8.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    Ovarian cancer
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        32.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    Renal cell carcinoma
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Squamous cell carcinoma of the head and neck
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        30.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      units
      Participants
    title
    Transitional carcinoma of the genitourinary (GU) tract
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        19.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Diffuse large B-cell lymphoma
denoms
  1. counts
    1. group Id
      OG000
      value
      382
    units
    Participants
description
ORR was percentage of participants with best overall response \[complete response (CR) or partial response (PR)\], per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
groups
  1. description
    Epacadostat 100 mg tablet orally BID in combination with pembrolizumab 200 mg intravenously every 3 weeks (Q3W).
    id
    OG000
    title
    Epacadostat 100 mg BID+ Pembrolizumab 200 mg Q3W
param Type
NUMBER
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
Approximately 54 months
title
Phase 2: Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice