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).
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
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There are 24 Locations for this study
Birmingham Alabama, 35294, United States
Los Angeles California, 90025, United States
Los Angeles California, 90033, United States
San Francisco California, 94115, United States
Aurora Colorado, 80045, United States
Fairway Kansas, 66205, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02215, United States
Burlington Massachusetts, 01805, United States
New York New York, 10016, United States
New York New York, 10032, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Fargo North Dakota, 58122, United States
Pittsburgh Pennsylvania, 15232, United States
North Sioux City South Dakota, 57104, United States
Nashville Tennessee, 37232, United States
Austin Texas, 78705, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84112, United States
Milwaukee Wisconsin, 53226, United States
Manchester , M20 4, United Kingdom
Oxford , OX3 7, United Kingdom
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