Ovarian Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

307

Study ID:

NCT02327078

Recruitment Status:

Completed

Sponsor:

Incyte Corporation

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There are 24 Locations for this study

See Locations Near You

UAB Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
The Angeles Clinic and Research Institute
Los Angeles California, 90025, United States
USC Norris Cancer Center
Los Angeles California, 90033, United States
UCSF - University of California San Francisco
San Francisco California, 94115, United States
University of Colorado Anschutz Medical Campus
Aurora Colorado, 80045, United States
The University of Kansas Clinical Research Center
Fairway Kansas, 66205, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21231, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Lahey Hospital & Medical Center
Burlington Massachusetts, 01805, United States
NYU Cancer Center
New York New York, 10016, United States
Columbia University, Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wake Forest Medical Center Boulevard
Winston-Salem North Carolina, 27157, United States
Sanford Research
Fargo North Dakota, 58122, United States
University of Pittsburgh School of Medicine
Pittsburgh Pennsylvania, 15232, United States
Sanford Research
North Sioux City South Dakota, 57104, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Texas Oncology Research
Austin Texas, 78705, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Oxford University Hospitals NHS Trust
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

307

Study ID:

NCT02327078

Recruitment Status:

Completed

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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