A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
Description
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).
Phase
Phase 1/2 - for trials that are a combination of phases 1 and 2.Inclusion and Exclusion 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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