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CompletedPhase 1 / Phase 2NCT02327078
Official study title

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

Study summary

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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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab and Epacadostat

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 14, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?24 U.S. locations

Locations may change over time.

Who runs it?Incyte Corporation

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Incyte Corporation
Interventions being studied
Drug: Nivolumab; Drug: Epacadostat; Drug: Chemotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UAB Comprehensive Cancer CenterBirmingham, Alabama
  • The Angeles Clinic and Research InstituteLos Angeles, California
  • USC Norris Cancer CenterLos Angeles, California
  • UCSF - University of California San FranciscoSan Francisco, California
  • University of Colorado Anschutz Medical CampusAurora, Colorado
  • The University of Kansas Clinical Research CenterFairway, Kansas
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Lahey Hospital & Medical CenterBurlington, Massachusetts
  • NYU Cancer CenterNew York, New York
  • Columbia University, Herbert Irving Comprehensive Cancer CenterNew York, New York
  • Duke University Medical CenterDurham, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 14, 2025. Always confirm current availability with the study team.

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