At a glance
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A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
In Brief
A Phase 2 clinical trial evaluating Nivolumab, Epacadostat, and 1 other intervention for B-cell Malignancies and 7 related conditions. Completed, enrolled 307 participants across 24 sites in 2 countries.
Detailed 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).
Study Details
Timeline
Interventions
specified dose and dosing schedule
oral twice daily continuous at the protocol-defined dose
Specified dose on specified days