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

This study is not yet open for participant recruitment.
Verified November 2017 by Incyte Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT03347123
First Posted: November 20, 2017
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Incyte Corporation
  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.

Condition Intervention Phase
Advanced or Metastatic Solid Tumors Drug: Epacadostat Drug: Nivolumab Drug: Ipilimumab Drug: Lirilumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

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

  • Phase 2: Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1) [ Time Frame: At protocol-specified timepoints up to approximately 18 months per subject. ]
    Defined as the percentage of subjects having complete response (CR) or partial response (PR).


Secondary Outcome Measures:
  • 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. ]
    Defined as the percentage of subjects having CR or PR.

  • 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. ]
    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.

  • 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. ]
    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.

  • 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. ]
    TEAEs defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.


Estimated Enrollment: 141
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group A
Epacadostat + nivolumab + ipilimumab
Drug: Epacadostat
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
Other Name: INCB024360
Drug: Nivolumab
Nivolumab at the protocol-specified dose and schedule.
Other Names:
  • Opdivo®
  • BMS-936558
Drug: Ipilimumab
Ipilimumab at the protocol-specified dose and schedule.
Other Names:
  • Yervoy®
  • BMS-734016
Experimental: Treatment Group B
Epacadostat + nivolumab + lirilumab
Drug: Epacadostat
Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
Other Name: INCB024360
Drug: Nivolumab
Nivolumab at the protocol-specified dose and schedule.
Other Names:
  • Opdivo®
  • BMS-936558
Drug: Lirilumab
Lirilumab at the protocol-specified dose and schedule.
Other Names:
  • IPH2102
  • BMS-986015

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347123


Contacts
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Gerard T. Kennealey, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03347123     History of Changes
Other Study ID Numbers: INCB 24360-208 (ECHO-208)
First Submitted: November 14, 2017
First Posted: November 20, 2017
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
Epacadostat
nivolumab
ipilimumab
lirilumab
solid tumor
melanoma
non-small cell lung cancer (NSCLC)
squamous cell carcinoma of the head and neck (SCCHN)
IDO inhibitor

Additional relevant MeSH terms:
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs