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NCT03361228 · REGISTRY CONDITION SEARCH

A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2020-05-21

The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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)

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outcome · POSTED

Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab

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outcome · POSTED

Phase 2 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a TEAE

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outcome · POSTED

Phase 1 Only: ORR With INCB001158 in Combination With Epacadostat ± Pembrolizumab

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outcome · POSTED

Disease Control Rate With INCB001158 in Combination With Epacadostat ± Pembrolizumab

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outcome · POSTED

Duration of Response With INCB001158 in Combination With Epacadostat ± Pembrolizumab

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outcome · POSTED

Progression-free Survival With INCB001158 in Combination With Epacadostat ± Pembrolizumab

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outcome · POSTED

Plasma Pharmacokinetic Profile of INCB001158 and Epacadostat

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * For Phase 1, subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (disease progression; subject intolerance is also allowable). * For Phase 2, subjects with the following tumor types who meet protocol-defined criteria: advanced or metastatic NSCLC, melanoma, urothelial carcinoma, SCCHN, SCLC, and CRC. * Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Resolution of all toxicities and any toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). Subjects with ≤ Grade 2 neuropathy are an exception and may enroll. * Adequate renal, hepatic, and hematologic functions per protocol-defined laboratory parameters within ≤ 7 days before treatment initiation. Exclusion Criteria: * Participation in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) before first dose. * Has received a prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study drug. * Prior chemotherapy or targeted small molecule therapy within 2 weeks before administration of study treatment. * Prior therapy with an IDO1 or arginase 1 inhibitor. * Active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Receipt of a live vaccine within 30 days before the first dose of study treatment. * Any history of serotonin syndrome after receiving serotonergic drugs. * Use of protocol-defined prior/concomitant therapy. * Known or suspected defect in the function of the urea cycle. * History of gastrointestinal condition that may affect drug absorption.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: INCB001158
    2. Drug: Epacadostat
    3. Drug: Pembrolizumab
    label
    INCB001158 + Epacadostat + Pembrolizumab
    type
    EXPERIMENTAL
  2. intervention Names
    1. Drug: INCB001158
    2. Drug: Epacadostat
    label
    INCB001158 + Epacadostat
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. INCB001158 + Epacadostat
    2. INCB001158 + Epacadostat + Pembrolizumab
    description
    Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
    name
    INCB001158
    type
    DRUG
  2. arm Group Labels
    1. INCB001158 + Epacadostat
    2. INCB001158 + Epacadostat + Pembrolizumab
    description
    Epacadostat at the protocol-defined dose administered orally twice daily.
    name
    Epacadostat
    other Names
    1. INCB024360
    type
    DRUG
  3. arm Group Labels
    1. INCB001158 + Epacadostat + Pembrolizumab
    description
    Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks.
    name
    Pembrolizumab
    other Names
    1. MK-3475
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
5
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    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)
    time Frame
    Up to approximately 12 months per subject
  2. description
    Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
    measure
    Phase 2 Only: Objective Response Rate (ORR) of INCB001158 in Combination With Epacadostat ± Pembrolizumab
    time Frame
    Up to approximately 12 months per subject
secondary Outcomes
  1. 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.
    measure
    Phase 2 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a TEAE
    time Frame
    Up to approximately 12 months per subject
  2. description
    Defined as percentage of subjects having a CR or PR based on investigator assessment per RECIST v1.1.
    measure
    Phase 1 Only: ORR With INCB001158 in Combination With Epacadostat ± Pembrolizumab
    time Frame
    Up to approximately 12 months per subject
  3. description
    Defined as percentage of subjects having CR, PR, or stable disease for at least 56 days based on investigator assessment per RECIST v1.1.
    measure
    Disease Control Rate With INCB001158 in Combination With Epacadostat ± Pembrolizumab
    time Frame
    Up to approximately 12 months per subject
  4. description
    Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
    measure
    Duration of Response With INCB001158 in Combination With Epacadostat ± Pembrolizumab
    time Frame
    Up to approximately 12 months per subject
  5. description
    Defined as the time from date of first dose of study treatment until the earliest date of disease progression (based on investigator assessment of per RECIST v1.1) or death due to any cause, if occurring sooner than progression.
    measure
    Progression-free Survival With INCB001158 in Combination With Epacadostat ± Pembrolizumab
    time Frame
    Up to approximately 12 months per subject
  6. description
    Noncompartmental method of analysis will be used to analyze the plasma concentrations of INCB001158 and epacadostat.
    measure
    Plasma Pharmacokinetic Profile of INCB001158 and Epacadostat
    time Frame
    Up to approximately 1 month
Full study description
brief Summary
The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      requested nct id
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      payload
      clinical indication matching status
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      true
      id
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      link basis
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      nct id
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      occurrences
      1. context exact
        NCT03361228
        end
        11
        exact text
        NCT03361228
        start
        0
      offset unit
      unicode_code_points
      query cond
      Small Intestine Cancer
      query disease state id
      ds-small-intestine-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
      source file sha256
      69c40ed34b17434f684079ec5635264bc5ad292871a86b835704fc99fa9d8157
      source json pointer
      /studies/94/protocolSection/identificationModule/nctId
      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      a4988e1c30524f0d5cb401d3b01a306dd5bde9c7198bb88fae856aea05d6f395

    Preserved source evidence · Not medical advice