NCT02327078

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• B-cell Malignancies
• Colorectal Cancer (CRC)
• Head and Neck Cancer
• Lung Cancer
• Lymphoma
• Melanoma
• Ovarian Cancer
• Glioblastoma

Interventions

Type	Name	Description
DRUG	Nivolumab	specified dose and dosing schedule
DRUG	Epacadostat	oral twice daily continuous at the protocol-defined dose
DRUG	Chemotherapy	Specified dose on specified days

Timeline

• Start date: 2014-11-26
• Primary completion: 2020-06-16
• Completion: 2020-06-16
• First posted: 2014-12-30
• Last updated: 2025-08-14
• Results posted: 2023-04-26

Locations

24 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study