Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03085914 · OUTCOME

Phases 1 and 2: Objective Response Rate (ORR)

A Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Participants With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723) · Source last updated 2022-09-23

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to Week 18

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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Analysis population: The full analysis set included all participants enrolled in the study who received at least 1 dose of epacadostat and have at least 1 postbaseline assessment or who discontinued epacadostat.

Groups in this outcome

Group A: Epa + Pembrolizumab + mFOLFOX6

Epacadostat (Epa) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.

Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine

Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.

Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin

Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.

Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent

Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

Group E: Epa + Pembrolizumab + Cyclophosphamide

Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.

Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent

Epa oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent

Epa oral BID continuousdaily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

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

Analysis denominator · Participants

GroupSource count
Group A: Epa + Pembrolizumab + mFOLFOX69
Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine9
Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin11
Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent9
Group E: Epa + Pembrolizumab + Cyclophosphamide13
Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent8
Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent11

Reported measurements

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A: Epa + Pembrolizumab + mFOLFOX60Not reportedNot reportedNot reportedNot reported
Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine1Not reportedNot reportedNot reportedNot reported
Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin0Not reportedNot reportedNot reportedNot reported
Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent0Not reportedNot reportedNot reportedNot reported
Group E: Epa + Pembrolizumab + Cyclophosphamide0Not reportedNot reportedNot reportedNot reported
Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent0Not reportedNot reportedNot reportedNot reported
Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent0Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A: Epa + Pembrolizumab + mFOLFOX65Not reportedNot reportedNot reportedNot reported
Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine2Not reportedNot reportedNot reportedNot reported
Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin3Not reportedNot reportedNot reportedNot reported
Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent2Not reportedNot reportedNot reportedNot reported
Group E: Epa + Pembrolizumab + Cyclophosphamide3Not reportedNot reportedNot reportedNot reported
Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent1Not reportedNot reportedNot reportedNot reported
Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        5
    title
    Partial Response
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      11
    4. group Id
      OG003
      value
      9
    5. group Id
      OG004
      value
      13
    6. group Id
      OG005
      value
      8
    7. group Id
      OG006
      value
      11
    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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
groups
  1. description
    Epacadostat (Epa) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.
    id
    OG000
    title
    Group A: Epa + Pembrolizumab + mFOLFOX6
  2. description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.
    id
    OG001
    title
    Group B: Epa + Pembrolizumab + Nab-Paclitaxel and Gemcitabine
  3. description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.
    id
    OG002
    title
    Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin
  4. description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
    id
    OG003
    title
    Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent
  5. description
    Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.
    id
    OG004
    title
    Group E: Epa + Pembrolizumab + Cyclophosphamide
  6. description
    Epa oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
    id
    OG005
    title
    Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent
  7. description
    Epa oral BID continuousdaily dosing at the protocol-defined dose in combination with pembrolizumab IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
    id
    OG006
    title
    Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
param Type
COUNT_OF_PARTICIPANTS
population Description
The full analysis set included all participants enrolled in the study who received at least 1 dose of epacadostat and have at least 1 postbaseline assessment or who discontinued epacadostat.
reporting Status
POSTED
time Frame
Up to Week 18
title
Phases 1 and 2: Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice