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NCT03361228 · OUTCOME

Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE)

A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors · Source last updated 2020-05-21

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to approximately 12 months per subject

What was measured

TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.

Analysis population: No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2

Groups in this outcome

INCB001158 50mg BID+ Epacadostat + Pembrolizumab

INCB001158 dosed at 50mg BID in combination with epacadostat (100 mg BID) and pembrolizumab (200 mg Q3W)

INCB001158 75 mg BID + Epacadostat + Pembrolizumab

INCB001158 dosed at 75mg BID in combination with epacadostat (100 mg BID)and pembrolizumab (200 mg 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
INCB001158 50mg BID+ Epacadostat + Pembrolizumab0
INCB001158 75 mg BID + Epacadostat + Pembrolizumab0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.
groups
  1. description
    INCB001158 dosed at 50mg BID in combination with epacadostat (100 mg BID) and pembrolizumab (200 mg Q3W)
    id
    OG000
    title
    INCB001158 50mg BID+ Epacadostat + Pembrolizumab
  2. description
    INCB001158 dosed at 75mg BID in combination with epacadostat (100 mg BID)and pembrolizumab (200 mg Q3W)
    id
    OG001
    title
    INCB001158 75 mg BID + Epacadostat + Pembrolizumab
population Description
No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2
reporting Status
POSTED
time Frame
Up to approximately 12 months per subject
title
Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE)
type
PRIMARY

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

Preserved source evidence · Not medical advice