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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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).

Official Title

A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)

Keywords

I/O naïve Melanoma (MEL) I/O Relapsed MEL I/O Refractory MEL Carcinoma, Non-Small-Cell Lung Cancer (NSCLC) Colorectal Cancer (CRC) Squamous Cell Carcinoma of the Head and Neck (SCCHN) Ovarian Cancer B Cell NHL Including DLBCL HL Glioblastoma Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Colorectal Neoplasms Head and Neck Neoplasms Nivolumab Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or female subjects, age 18 years or older
  • Subjects with histologically or cytologically confirmed NSCLC, 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

You CAN'T join if...

  • 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

Locations

  • San Francisco, California, United States
  • Los Angeles, California, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Incyte Corporation
ID
NCT02327078
Phase
Phase 1/2
Lead Scientist
Adil Daud
Study Type
Interventional
Last Updated
September 20, 2017
I’m interested in this study!