Clinical Trials /

A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)

NCT03347123

Description:

The purpose of this study is to determine the safety, tolerability, and efficacy of epacadostat when given in combination with nivolumab and ipilimumab, and in combination with nivolumab and lirilumab, in subjects with advanced or metastatic malignancies.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)
  • Official Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)

Clinical Trial IDs

  • ORG STUDY ID: INCB 24360-208 (ECHO-208)
  • NCT ID: NCT03347123

Conditions

  • Advanced or Metastatic Solid Tumors

Interventions

DrugSynonymsArms
EpacadostatINCB024360Treatment Group A
NivolumabOpdivo®, BMS-936558Treatment Group A
IpilimumabYervoy®, BMS-734016Treatment Group A
LirilumabIPH2102, BMS-986015Treatment Group B

Purpose

The purpose of this study is to determine the safety, tolerability, and efficacy of epacadostat when given in combination with nivolumab and ipilimumab, and in combination with nivolumab and lirilumab, in subjects with advanced or metastatic malignancies.

Trial Arms

NameTypeDescriptionInterventions
Treatment Group AExperimentalEpacadostat + nivolumab + ipilimumab
  • Epacadostat
  • Nivolumab
  • Ipilimumab
Treatment Group BExperimentalEpacadostat + nivolumab + lirilumab
  • Epacadostat
  • Nivolumab
  • Lirilumab

Eligibility Criteria

        Inclusion Criteria:

          -  During Phase 1, subjects with locally advanced or metastatic solid tumors with disease
             progression on or after treatment with available therapies, or who are intolerant to
             treatment, or who refuse standard treatment.

          -  During Phase 2, subjects with advanced cancer who have received at least one prior
             therapy or are treatment naive, depending on the specified tumor type.

          -  Presence of measurable disease per RECIST v1.1.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Expected survival of ≥ 12 weeks.

        Exclusion Criteria:

          -  Laboratory and medical history parameters not within the Protocol-defined range.

          -  Receipt of anticancer medications or investigational drugs within Protocol-defined
             time frames.

          -  Previous radiotherapy within 7 days of Cycle 1 Day 1.

          -  Known active central nervous system metastases and/or carcinomatous meningitis.

          -  Prior treatment with any immune checkpoint inhibitor and/or an IDO inhibitor.

          -  Active infection requiring systemic therapy.

          -  Any active or inactive autoimmune disease or syndrome
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Time Frame:Up to approximately 18 months per subject.
Safety Issue:
Description:TEAEs defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.

Secondary Outcome Measures

Measure:Phase 1: ORR based on RECIST v1.1
Time Frame:Every 8 weeks for 12 months and then every 12 weeks, up to approximately 18 months per subject.
Safety Issue:
Description:Defined as the percentage of subjects having CR or PR.
Measure:Phase 1 & Phase 2: Duration of response
Time Frame:Every 8 weeks for 12 months and then every 12 weeks, up to approximately 18 months per subject.
Safety Issue:
Description:Defined as the time from the earliest date of CR or PR until the earliest date at which progression criteria are met or date of death due to any cause, whichever occurs first.
Measure:Phase 1 & Phase 2: Progression-free survival
Time Frame:Every 8 weeks for 12 months and then every 12 weeks, up to approximately 18 months per subject.
Safety Issue:
Description:Defined as the time from the start of combination therapy until the earliest date at which progression criteria are met per RECIST v1.1 or date of death due to any cause, whichever occurs first.
Measure:Phase 2: Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Time Frame:Screening through up to 150 days after end of treatment, up to approximately 18 months per subject.
Safety Issue:
Description:TEAEs defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Epacadostat
  • nivolumab
  • ipilimumab
  • lirilumab
  • solid tumor
  • melanoma
  • non-small cell lung cancer (NSCLC)
  • squamous cell carcinoma of the head and neck (SCCHN)
  • IDO inhibitor

Last Updated

February 13, 2018