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

Phase 1/2 Completed 307 enrolled Incyte Corporation Bristol-Myers Squibb · collab

Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2014-11-26
Primary completion: 2020-06-16
Completion: 2020-06-16

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Epacadostat	Small molecule	25 mg	Oral
Subject	Epacadostat	Small molecule	50 mg	Oral
Subject	Epacadostat	Small molecule	100 mg	Oral
Subject	Epacadostat	Small molecule	300 mg	Oral
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous
Subject	Nivolumab	Monoclonal antibody	360 mg	Intravenous
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous
Background	Carboplatin	Small molecule	—	Intravenous
Background	Cisplatin	Other / unclassified	—	Intravenous
Background	Paclitaxel	Small molecule	—	Intravenous
Background	Pemetrexed	Small molecule	—	Intravenous
Background	fluorouracil	Small molecule	—	Intravenous

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

Summary

Timeline

Drugs

Indications