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NCT02327078 · OUTCOME

Phase 2: Objective Response Rate (ORR) in Participants With Select Solid Tumors Per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 for Participants With Solid Tumors and Per Cheson Criteria for Participants With DLBCL

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From first dose up end of the study (up to approximately 6 years)

What was measured

ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per RECIST v1.1. CR per RECIST v 1.1 was defined as disappearance of all target lesions. PR per RECIST v 1.1 was defined as At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. Data is reported as per dose received by the participants with a particular cancer type. CR per Cheson criteria was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR per Cheson criteria was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses.

Analysis population: The Phase 2 Full Analysis Population includes all participants enrolled in the study who received 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 percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Epacadostat 100 mg + Nivolumab 240 in Colorectal Cancer3.8Not reportedNot reportedNot reportedNot reported
Phase 2: Epacadostat 300 mg + Nivolumab 240 mg in DLBCL0.0Not reportedNot reportedNot reportedNot reported
Phase 2: Epacadostat 100/300 mg + Nivolumab 240 mg in Melanoma(I/O Naive)62.0Not reportedNot reportedNot reportedNot reported
Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Relapsed)28.6Not reportedNot reportedNot reportedNot reported
Phase 2 Epacadostat 100mg + Nivolumab 480 mg in Melanoma (I/O Refractory)28.6Not reportedNot reportedNot reportedNot reported
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in NSCLC20.7Not reportedNot reportedNot reportedNot reported
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Ovarian Cancer13.8Not reportedNot reportedNot reportedNot reported
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in SCCHN25.8Not reportedNot reportedNot reportedNot reported
Phase 2 Epacadostat 100/300 mg + Nivolumab 240 mg in Glioblastoma0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3.8
      2. group Id
        OG001
        value
        0.0
      3. group Id
        OG002
        value
        62.0
      4. group Id
        OG003
        value
        28.6
      5. group Id
        OG004
        value
        28.6
      6. group Id
        OG005
        value
        20.7
      7. group Id
        OG006
        value
        13.8
      8. group Id
        OG007
        value
        25.8
      9. group Id
        OG008
        value
        0.0
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
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per RECIST v1.1. CR per RECIST v 1.1 was defined as disappearance of all target lesions. PR per RECIST v 1.1 was defined as At least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the Baseline sum diameters. Data is reported as per dose received by the participants with a particular cancer type. CR per Cheson criteria was defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms. PR per Cheson criteria was defined as at least a 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses.
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
NUMBER
population Description
The Phase 2 Full Analysis Population includes all participants enrolled in the study who received 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: Objective Response Rate (ORR) in Participants With Select Solid Tumors Per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 for Participants With Solid Tumors and Per Cheson Criteria for Participants With DLBCL
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice