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. 2018 Feb 6;2018(2):CD011123. doi: 10.1002/14651858.CD011123.pub2

NCT02752074.

Study name A phase III 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).
Methods Phase III RCT.
Participants Metastatic melanoma.
Estimated enrolment: 600.
Interventions Two‐arm trial:

  • Pembrolizumab IV every 3 weeks starting at Day 1 (Week 1), and epacadostat orally daily starting at Day 1 (Week 1).

  • Pembrolizumab IV every 3 weeks starting at Day 1 (Week 1).
Outcomes Primary outcomes:

  • progression‐free survival; and

  • overall survival.


Secondary outcomes:

  • objective response rate; and

  • safety and tolerability.
Starting date June 2016.
Contact information Merck Sharp & Dohme Corp 1‐888‐577‐8839
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