Status:

TERMINATED

A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)

Lead Sponsor:

Incyte Corporation

Conditions:

Solid Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of epacadostat when given in combination with nivolumab and ipilimumab, and in combination with nivolumab and lirilumab...

Eligibility Criteria

Inclusion

  • During Phase 1, participant with locally advanced or metastatic solid tumors with disease progression on or after treatment with available therapies, or who are intolerant to treatment, or who refuse standard treatment.
  • During Phase 2, participant with advanced cancer who have received at least one prior therapy or are treatment naive, depending on the specified tumor type.
  • Presence of measurable disease per RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Expected survival of ≥ 12 weeks.

Exclusion

  • Laboratory and medical history parameters not within the Protocol-defined range.
  • Receipt of anticancer medications or investigational drugs within Protocol-defined time frames.
  • Previous radiotherapy within 7 days of Cycle 1 Day 1.
  • Known active central nervous system metastases and/or carcinomatous meningitis.
  • Prior treatment with any immune checkpoint inhibitor and/or an IDO inhibitor.
  • Active infection requiring systemic therapy.
  • Any active or inactive autoimmune disease or syndrome

Key Trial Info

Start Date :

March 21 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 29 2021

Estimated Enrollment :

11 Patients enrolled

Trial Details

Trial ID

NCT03347123

Start Date

March 21 2018

End Date

January 29 2021

Last Update

February 28 2022

Active Locations (5)

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Page 1 of 2 (5 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

The Angeles Clinic and Research Institute

Los Angeles, California, United States, 90025

3

John Wayne Cancer Institute

Santa Monica, California, United States, 90404

4

Duke University Medical Center

Durham, North Carolina, United States, 27710