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NCT02327078 · OUTCOME

Phase 2: Progression Free Survival (PFS)

A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204) · Source last updated 2025-08-14

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From first dose up end of the study (up to approximately 6 years)

What was measured

PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 or death due to any cause, whichever occurs first.

Analysis population: The Phase 2 Full Analysis Population includes all participants enrolled in the study who take at least 1 dose of study drug. The data is reported per cancer type in this outcome measure.

Groups in this outcome

Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer

Participants with Colorectal Cancer received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.

Phase 2: Epacadostat 300 mg + Nivolumab 240 mg in DLBCL

Participants with DLBCL received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.

Phase 2: Epacadostat 100/300 mg + Nivolumab 240 mg in Melanoma(I/O Naive)

Participants with Melanoma(I/O Naive) received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.

Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Relapsed)

Participants with Melanoma (I/O Relapsed) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.

Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory)

Participants with Melanoma (I/O Refractory) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.

Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in NSCLC

Participants with NSCLC received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.

Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer

Participants with Ovarian Cancer received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.

Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN

Participants with SCCHN received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.

Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Glioblastoma

Participants with Glioblastoma received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.

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

Analysis denominator · Participants

GroupSource count
Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer26
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg in DLBCL18
Phase 2: Epacadostat 100/300 mg + Nivolumab 240 mg in Melanoma(I/O Naive)50
Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Relapsed)7
Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory)7
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in NSCLC58
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer29
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN31
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Glioblastoma33

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer1.78Not reported1.741.81Not reported
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg in DLBCL1.64Not reported1.353.52Not reported
Phase 2: Epacadostat 100/300 mg + Nivolumab 240 mg in Melanoma(I/O Naive)NANot reported9.51NAMedian and upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with events.
Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Relapsed)1.76Not reported0.46NAUpper limit of 95% CI was not estimable due to low number of participants with events.
Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory)2.55Not reported0.59NAUpper limit of 95% CI was not estimable due to low number of participants with events.
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in NSCLC1.88Not reported1.782.04Not reported
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer1.88Not reported1.683.52Not reported
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN3.62Not reported1.789.08Not reported
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Glioblastoma1.84Not reported1.782.63Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.74
        upper Limit
        1.81
        value
        1.78
      2. group Id
        OG001
        lower Limit
        1.35
        upper Limit
        3.52
        value
        1.64
      3. comment
        Median and upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with events.
        group Id
        OG002
        lower Limit
        9.51
        upper Limit
        NA
        value
        NA
      4. comment
        Upper limit of 95% CI was not estimable due to low number of participants with events.
        group Id
        OG003
        lower Limit
        0.46
        upper Limit
        NA
        value
        1.76
      5. comment
        Upper limit of 95% CI was not estimable due to low number of participants with events.
        group Id
        OG004
        lower Limit
        0.59
        upper Limit
        NA
        value
        2.55
      6. group Id
        OG005
        lower Limit
        1.78
        upper Limit
        2.04
        value
        1.88
      7. group Id
        OG006
        lower Limit
        1.68
        upper Limit
        3.52
        value
        1.88
      8. group Id
        OG007
        lower Limit
        1.78
        upper Limit
        9.08
        value
        3.62
      9. group Id
        OG008
        lower Limit
        1.78
        upper Limit
        2.63
        value
        1.84
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    2. group Id
      OG001
      value
      18
    3. group Id
      OG002
      value
      50
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      58
    7. group Id
      OG006
      value
      29
    8. group Id
      OG007
      value
      31
    9. group Id
      OG008
      value
      33
    units
    Participants
description
PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 or death due to any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with Colorectal Cancer received epacadostat 100 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    OG000
    title
    Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer
  2. description
    Participants with DLBCL received epacadostat 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    OG001
    title
    Phase 2: Epacadostat 300 mg + Nivolumab 240 mg in DLBCL
  3. description
    Participants with Melanoma(I/O Naive) received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    OG002
    title
    Phase 2: Epacadostat 100/300 mg + Nivolumab 240 mg in Melanoma(I/O Naive)
  4. description
    Participants with Melanoma (I/O Relapsed) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    OG003
    title
    Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Relapsed)
  5. description
    Participants with Melanoma (I/O Refractory) received epacadostat 100 mg BID in combination with nivolumab 480 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    OG004
    title
    Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory)
  6. description
    Participants with NSCLC received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    OG005
    title
    Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in NSCLC
  7. description
    Participants with Ovarian Cancer received epacadostat 100 mg or 300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    OG006
    title
    Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer
  8. description
    Participants with SCCHN received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    OG007
    title
    Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN
  9. description
    Participants with Glioblastoma received epacadostat 100/300 mg BID in combination with nivolumab 240 mg IV infusion Q2W on Days 1, 15, 29, and 43 of each 8-week cycle.
    id
    OG008
    title
    Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Glioblastoma
param Type
MEDIAN
population Description
The Phase 2 Full Analysis Population includes all participants enrolled in the study who take at least 1 dose of study drug. The data is reported per cancer type in this outcome measure.
reporting Status
POSTED
time Frame
From first dose up end of the study (up to approximately 6 years)
title
Phase 2: Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice