A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
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).
Checked against the public recordLast updated Aug 14, 2025 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.