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NCT02327078 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)
A Phase 1 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 307
- Enrollment target
NCT02327078: Completed Phase 1 study, sponsored by Incyte Corporation.
NCT02327078 is a Phase 1 study that has completed, run by Incyte Corporation. The registered enrollment target is 307 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (412% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02327078, a Phase 1 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 307 participants
- Enrollment target
Study 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).
Primary Outcome
A DLT was defined as occurrence of any treatment-emergent adverse event (TEAE) in Phase 1 Parts 1 and 2. DLT included all TEAE of specified grades such as 1) Hematologic toxicities - any Grade 4 thrombocytopenia or neutropenia, anemia, febrile neutropenia, ≥ Grade 3 hemolysis, thrombocytopenia and 2) Nonhematologic toxicities - Grade 4 AE, nausea, vomiting, or diarrhea, electrolyte abnormality, ≥ Grade 3 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin elevati
Interventions
- DRUG Epacadostat
- DRUG Nivolumab
- DRUG Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2014-11-26 |
| Est. Completion | 2020-06-16 |
| Phase | Phase 1 |
What the finished NCT02327078 record still lists
NCT02327078 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (412% higher).
The record links to 0 conditions, and to 3 interventions - of which Epacadostat is the first listed.
NCT02327078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02327078 about?
NCT02327078 is a clinical study titled "A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)". 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 epacad...
What is the current status of trial NCT02327078?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 307 participants. The study started on 2014-11-26. Estimated completion is 2020-06-16.
What interventions are being tested in trial NCT02327078?
The interventions under investigation include: Epacadostat (DRUG), Nivolumab (DRUG), Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT02327078?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02327078's enrollment target sits among peer trials
307 124th of 2000 higher than 1,877 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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