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Brief Title: A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Official Title: A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Study ID: NCT02327078
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Lance Leopold
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR