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

Completed · Phase 1/Phase 2

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

In brief

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).

Key facts

Study ID

NCT02327078

Run by

Incyte Corporation

People needed

307

Starts

2014-11-26

Expected to finish

2020-06-16

Last updated by the study team

2025-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States
• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• USC Norris Cancer Center — Los Angeles, California, United States
• UCSF - University of California San Francisco — San Francisco, California, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• The University of Kansas Clinical Research Center — Fairway, Kansas, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
• NYU Cancer Center — New York, New York, United States
• Columbia University, Herbert Irving Comprehensive Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest Medical Center Boulevard — Winston-Salem, North Carolina, United States
• Sanford Research — Fargo, North Dakota, United States
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
• Sanford Research — North Sioux City, South Dakota, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Oncology Research — Austin, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Utah Cancer Specialists — Salt Lake City, Utah, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• The Christie NHS Foundation Trust — Manchester, United Kingdom
• Oxford University Hospitals NHS Trust — Oxford, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.