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NCT03277352 · REGISTRY CONDITION SEARCH

INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies

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
2021-07-22

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.

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 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]

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outcome · POSTED

Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST

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outcome · POSTED

Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1

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outcome · POSTED

Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST

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outcome · POSTED

Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST

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outcome · POSTED

Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST

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outcome · POSTED

Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST

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outcome · POSTED

Phase 1 & Phase 2: Overall Survival

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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: * Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * Phase 1: Subjects with advanced or metastatic solid tumors. * Phase 1: Subjects who have disease progression after treatment with available therapies. * Phase 2: Subjects with advanced or metastatic melanoma, RCC, and urothelial carcinoma. * Presence of measurable disease based on RECIST v1.1. * Eastern Cooperative Oncology Group performance status of 0 or 1. Exclusion Criteria: * Laboratory and medical history parameters not within the Protocol-defined range * Prior treatment with any tumor necrosis factor super family agonist. * Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * Has not recovered to ≤ Grade 1 from toxic effects of prior therapy. * Active autoimmune disease. * Known active central nervous system metastases and/or carcinomatous meningitis. * Evidence of active, noninfectious pneumonitis or history of interstitial lung disease. * Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation. * Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies).
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    INCAGN01876 in combination with pembrolizumab and epacadostat
    intervention Names
    1. Drug: INCAGN01876
    2. Drug: Epacadostat
    3. Drug: Pembrolizumab
    label
    INCAGN01876 + Pembrolizumab + Epacadostat
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. INCAGN01876 + Pembrolizumab + Epacadostat
    description
    In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
    name
    INCAGN01876
    type
    DRUG
  2. arm Group Labels
    1. INCAGN01876 + Pembrolizumab + Epacadostat
    description
    Epacadostat will be self-administered orally at the protocol-defined dose.
    name
    Epacadostat
    other Names
    1. INCB024360
    type
    DRUG
  3. arm Group Labels
    1. INCAGN01876 + Pembrolizumab + Epacadostat
    description
    Pembrolizumab will be administered IV at the protocol-defined dose.
    name
    Pembrolizumab
    other Names
    1. Keytruda®
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
10
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    A TEAE is any adverse event (AE) either reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
    measure
    Phase 1 and Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
    time Frame
    Screening through 60 days after end of treatment, up to approximately 18 months
  2. description
    Defined as the percentage of participants having a CR or PR based on investigator assessment per RECIST v1.1.
    measure
    Phase 1 and Phase 2 : ORR Based on RECIST v1.1 and mRECIST
    time Frame
    Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
  3. description
    Defined as the percentage of checkpoint inhibitor-naive melanoma participants who have a CR based on investigator assessment per RECIST v1.1
    measure
    Phase 2: Complete Response Rate (CRR) Based on RECIST v1.1
    time Frame
    Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
secondary Outcomes
  1. description
    Defined as the percentage of participants having CR, PR, or stable disease (SD) based on investigator assessment per RECIST v1.1.
    measure
    Phase 1 & Phase 2: Disease Control Rate Based on RECIST v1.1 and mRECIST
    time Frame
    Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months.
  2. description
    Defined as the time from the earliest date of disease response (CR or PR) until earliest date of disease progression or death due to any cause.
    measure
    Phase 1 & Phase 2: Duration of Response Based on RECIST v1.1 and mRECIST
    time Frame
    Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
  3. description
    Defined as time from first report of SD or better until disease progression or death from any cause.
    measure
    Phase 1 & Phase 2: Duration of Disease Control Based on RECIST v1.1 and mRECIST
    time Frame
    Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
  4. description
    Defined as the time from the start of combination therapy until the earliest date of disease progression or death due to any cause.
    measure
    Phase 1 & Phase 2: Progression-free Survival Based on RECIST v1.1 and mRECIST
    time Frame
    Assessed every 9 weeks for 12 months, then every 12 weeks, up to 18 months
  5. description
    Defined as the time from the start of combination therapy until death due to any cause.
    measure
    Phase 1 & Phase 2: Overall Survival
    time Frame
    At 1 year and 2 years.
Full study description
brief Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice