Overview

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

Status:
Completed
Trial end date:
2020-07-10
Target enrollment:
0
Participant gender:
All
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/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Incyte Corporation
Collaborator:
Bristol-Myers Squibb
Treatments:
Antibodies, Monoclonal
Nivolumab
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