Skin Cancer
A Phase 3 Study of Pembrolizumab + Epacadostat or placebo in Subjects with Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
Incyte Study ID:
INCB 24360-301 (ECHO-301)
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
Merck Sharp & Dohme Corp.
Study Contact Information:
Clinical Study Purpose
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
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
Merck Sharp & Dohme Corp.
DATE
Jun 2016 - Jan 2018
TYPE
Interventional
PHASE
Phase 3
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Location
Status
Location
Birmingham, AL, US
Status
Active, not recruiting
Location
Scottsdale, AZ, US
Status
Active, not recruiting
Location
Little Rock, Arkansas, US
Status
Active, not recruiting
Location
Los Angeles, CA, US
Status
Active, not recruiting
Location
San Francisco, CA, US
Status
Active, not recruiting
Location
Santa Barbara, CA, US
Status
Active, not recruiting
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Have histologically or cytologically confirmed melanoma
- Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy
Exclusion Criteria
- Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy)
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or IDO1 inhibitor or any other antibody or drug specifically targeting checkpoint pathways other than anti-CTLA-4 which is permitted in the adjuvant setting
Protocol Summary
Incyte Study ID:
INCB 24360-301 (ECHO-301)
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Interventions:
Drug
Enrollment:
706
Primary Outcome
Open
Secondary Outcome
Open