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NCT02178722 · OUTCOME

Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events

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

An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.

Analysis population: The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).

Groups in this outcome

Phase 1: Epacadostat 25 mg BID

Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.

Phase 1: Epacadostat 50 mg BID

Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.

Phase 1: Epacadostat 100 mg BID

Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.

Phase 1: Epacadostat 300 mg BID

Epacadostat 300 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
Phase 1: Epacadostat 25 mg BID4
Phase 1: Epacadostat 50 mg BID20
Phase 1: Epacadostat 100 mg BID18
Phase 1: Epacadostat 300 mg BID20

Reported measurements

SAE
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Epacadostat 25 mg BID0Not reportedNot reportedNot reportedNot reported
Phase 1: Epacadostat 50 mg BID40.0Not reportedNot reportedNot reportedNot reported
Phase 1: Epacadostat 100 mg BID50.0Not reportedNot reportedNot reportedNot reported
Phase 1: Epacadostat 300 mg BID45.0Not reportedNot reportedNot reportedNot reported
TEAS
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Epacadostat 25 mg BID100.Not reportedNot reportedNot reportedNot reported
Phase 1: Epacadostat 50 mg BID95.0Not reportedNot reportedNot reportedNot reported
Phase 1: Epacadostat 100 mg BID94.4Not reportedNot reportedNot reportedNot reported
Phase 1: Epacadostat 300 mg BID100.Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        40.0
      3. group Id
        OG002
        value
        50.0
      4. group Id
        OG003
        value
        45.0
    title
    SAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        100.
      2. group Id
        OG001
        value
        95.0
      3. group Id
        OG002
        value
        94.4
      4. group Id
        OG003
        value
        100.
    title
    TEAS
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      20
    3. group Id
      OG002
      value
      18
    4. group Id
      OG003
      value
      20
    units
    Participants
description
An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.
groups
  1. description
    Epacadostat 25 mg tablet orally twice daily (BID) starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    OG000
    title
    Phase 1: Epacadostat 25 mg BID
  2. description
    Epacadostat 50 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    OG001
    title
    Phase 1: Epacadostat 50 mg BID
  3. description
    Epacadostat 100 mg tablet orally BID starting on Cycle 1 Day 1 in combination with pembrolizumab 2 mg/kg or 200mg administered intravenously every 3 weeks (Q3W) starting on Cycle 1 Day 1.
    id
    OG002
    title
    Phase 1: Epacadostat 100 mg BID
  4. description
    Epacadostat 300 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
    OG003
    title
    Phase 1: Epacadostat 300 mg BID
param Type
NUMBER
population Description
The safety evaluable population included all participants enrolled in the study who received at least 1 dose of study drug (epacadostat or pembrolizumab).
reporting Status
POSTED
time Frame
Approximately 54 months
title
Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice