A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/14/2018 |
Start Date: | January 29, 2018 |
End Date: | October 2021 |
A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies (ECHO-208)
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, in subjects with advanced or metastatic malignancies.
epacadostat when given in combination with nivolumab and ipilimumab, and in combination with
nivolumab and lirilumab, in subjects with advanced or metastatic malignancies.
Inclusion Criteria:
- During Phase 1, subjects 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, subjects 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 Criteria:
- 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
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
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Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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