NCT02752074

A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Pembrolizumab (MK-3475) in Combination With Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 706 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in participants with unresectable or metastatic melanoma

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	pembrolizumab + epacadostat	* Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1) * Epacadostat will be administered orally daily starting at Day 1 (Week 1)
DRUG	pembrolizumab + placebo	* Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1) * Placebo will be administered orally daily starting at Day 1 (Week 1)

Timeline

• Start date: 2016-06-21
• Primary completion: 2018-01-08
• Completion: 2019-08-16
• First posted: 2016-04-26
• Last updated: 2025-08-24
• Results posted: 2019-05-15

Locations

129 sites across 23 countries: United States, Australia, Belgium, Canada, Chile, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom