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

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ClinicalTrials.gov Identifier: NCT03347123
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Solid Tumors Drug: Epacadostat Drug: Nivolumab Drug: Ipilimumab Drug: Lirilumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 141 participants
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)
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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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

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

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, California
The Angeles Clinic and Research Institute Recruiting
Los Angeles, California, United States, 90025
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Pia Baumann, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03347123     History of Changes
Other Study ID Numbers: INCB 24360-208 (ECHO-208)
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
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