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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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