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A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)

NCT ID: NCT02327078

Last Updated: 2025-08-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-26

Study Completion Date

2020-06-16

Brief Summary

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This is a Phase 1/2, open label study. Phase 1 consists of 2 parts. Part 1 is a dose-escalation assessment of the safety and tolerability of epacadostat administered with nivolumab in subjects with select advanced solid tumors and lymphomas. Part 2 will evaluate the safety and tolerability of epacadostat in combination with nivolumab and chemotherapy in subjects with squamous cell carcinoma of head and neck (SCCHN) and non-small cell lung cancer (NSCLC).

Phase 2 will include expansion cohorts in 7 tumor types, including melanoma, NSCLC, SCCHN, colorectal cancer, ovarian cancer, glioblastoma and diffuse large B-cell lymphoma (DLBCL).

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Detailed Description

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Conditions

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B-cell Malignancies Colorectal Cancer (CRC) Head and Neck Cancer Lung Cancer Lymphoma Melanoma Ovarian Cancer Glioblastoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1 Part 1 Epacadostat 25mg BID +Nivolumab

Epacadostat 25mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

specified dose and dosing schedule

Epacadostat

Intervention Type DRUG

oral twice daily continuous at the protocol-defined dose

Phase 1 Part 1 Epacadostat 50mg BID +Nivolumab

Epacadostat 50mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

specified dose and dosing schedule

Epacadostat

Intervention Type DRUG

oral twice daily continuous at the protocol-defined dose

Phase 1 Part 1 Epacadostat 100mg BID +Nivolumab

Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

specified dose and dosing schedule

Epacadostat

Intervention Type DRUG

oral twice daily continuous at the protocol-defined dose

Phase 1 Part 1 Epacadostat 300mg BID +Nivolumab

Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab administered intravenously (IV) at 3mg/kg Q2W.

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

specified dose and dosing schedule

Epacadostat

Intervention Type DRUG

oral twice daily continuous at the protocol-defined dose

Phase 1 Part 2 Epacadostat 100mg BID +Nivolumab +5-FU/Platinum

Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360mg Q3W and 5-FU/Platinum( Carboplatin or Cisplatin+5-Fluorouracil) administered intravenously (IV).

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

specified dose and dosing schedule

Epacadostat

Intervention Type DRUG

oral twice daily continuous at the protocol-defined dose

Chemotherapy

Intervention Type DRUG

Specified dose on specified days

Phase 1 Part 2 Epacadostat 100mg BID +Pemetrexed/Platinum

Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360 mg Q3W and Pemetrexed/Platinum (Carboplatin orCisplatin+Pemetrexed) administered intravenously (IV).

Group Type EXPERIMENTAL

Epacadostat

Intervention Type DRUG

oral twice daily continuous at the protocol-defined dose

Chemotherapy

Intervention Type DRUG

Specified dose on specified days

Phase 1 Part 2 Epacadostat 100mg BID +Paclitaxel/Platinum

Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 360 mg Q3W and Paclitaxel/Platinum(Carboplatin+Cisplatin+Paclitaxel)administered intravenously (IV).

Group Type EXPERIMENTAL

Epacadostat

Intervention Type DRUG

oral twice daily continuous at the protocol-defined dose

Chemotherapy

Intervention Type DRUG

Specified dose on specified days

Phase 2 Epacadostat 100mg BID + Nivolumab

Epacadostat 100mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 240mg Q2W or 480 mg Q4W based on tumor type administered intravenously (IV).

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

specified dose and dosing schedule

Epacadostat

Intervention Type DRUG

oral twice daily continuous at the protocol-defined dose

Phase 2 Epacadostat 300mg BID + Nivolumab

Epacadostat 300mg oral twice daily (BID) continuous daily dosing in combination with Nivolumab 240mg Q2W administered intravenously (IV).

Group Type EXPERIMENTAL

Nivolumab

Intervention Type DRUG

specified dose and dosing schedule

Epacadostat

Intervention Type DRUG

oral twice daily continuous at the protocol-defined dose

Interventions

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Nivolumab

specified dose and dosing schedule

Intervention Type DRUG

Epacadostat

oral twice daily continuous at the protocol-defined dose

Intervention Type DRUG

Chemotherapy

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects, age 18 years or older
* Subjects with histologically or cytologically confirmed NSCLC, MEL (including I/O relapsed MEL or I/O refractory MEL), CRC, SCCHN, ovarian cancer, recurrent B cell NHL or HL, or glioblastoma
* Presence of measurable disease by RECIST v1.1 for solid tumors or Cheson criteria for B cell NHL (including DLBCL) or HL. For subjects with glioblastoma, presence of measurable disease is not required.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Fresh baseline tumor biopsies (defined as a biopsy specimen taken since completion of the most recent prior chemotherapy regimen) are required for all cohorts except glioblastoma

Exclusion Criteria

* Laboratory and medical history parameters not within Protocol-defined range
* Currently pregnant or breastfeeding
* Subjects who have received prior immune checkpoint inhibitors or an IDO inhibitor (except select Phase 2 cohorts evaluating I/O relapsed or I/O refractory MEL). Subjects who have received experimental vaccines or other immune therapies should be discussed with the medical monitor to confirm eligibility
* Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
* Subjects with any active or inactive autoimmune process
* Evidence of interstitial lung disease or active, noninfectious pneumonitis
* Subjects with any active or inactive autoimmune process
* Ocular MEL
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Incyte Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lance Leopold

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

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UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Site Status

USC Norris Cancer Center

Los Angeles, California, United States

Site Status

UCSF - University of California San Francisco

San Francisco, California, United States

Site Status

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

The University of Kansas Clinical Research Center

Fairway, Kansas, United States

Site Status

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

Site Status

NYU Cancer Center

New York, New York, United States

Site Status

Columbia University, Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Wake Forest Medical Center Boulevard

Winston-Salem, North Carolina, United States

Site Status

Sanford Research

Fargo, North Dakota, United States

Site Status

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Site Status

Sanford Research

North Sioux City, South Dakota, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Texas Oncology Research

Austin, Texas, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Utah Cancer Specialists

Salt Lake City, Utah, United States

Site Status

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Oxford University Hospitals NHS Trust

Oxford, , United Kingdom

Site Status

Countries

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United States United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-002423-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INCB 24360-204 / ECHO-204

Identifier Type: -

Identifier Source: org_study_id

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