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)
2 other identifiers
interventional
706
23 countries
129
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2016
Typical duration for phase_3
129 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2016
CompletedStudy Start
First participant enrolled
June 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2018
CompletedResults Posted
Study results publicly available
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2019
CompletedAugust 24, 2025
August 1, 2025
1.6 years
April 22, 2016
February 26, 2019
August 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-free Survival
Progression-free survival, defined as the time from date of randomization until the earliest date of disease progression, as determined by independent central review of objective radiographic disease assessments per RECIST 1.1, or death from any cause, whichever comes first.
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
Overall Survival (OS) Rate at 6 Months
Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.
Assessed every 9 weeks of study participation which is estimated to be 24 months. The OS rate at Month 6 was calculated.
Secondary Outcomes (8)
Objective Response Rate (ORR)
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events
Through up to 90 days after end of treatment, up to 27 months
Duration of Response (DOR)
Assessed every 9 weeks for duration of study participation which is estimated to be 24 months
Apparent Oral Clearance (CL/F) of Epacadostat
Through up to 30 days after the end of treatment, up to 25 months
Apparent Volume of Distribution (Vd/F) of Epacadostat
Through up to 30 days after the end of treatment, up to 25 months
- +3 more secondary outcomes
Study Arms (2)
Pembrolizumab + Epacadostat
EXPERIMENTALPembrolizumab + Epacadostat
Pembrolizumab + Placebo
ACTIVE COMPARATORPembrolizumab + Placebo
Interventions
* 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)
* 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)
Eligibility Criteria
You may qualify if:
- Have histologically or cytologically confirmed melanoma
- Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy
- A minimum of 1 measurable lesion by CT or MRI
- Provide a baseline tumor biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
You may not qualify if:
- 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
- Has received prior adjuvant therapy, monoclonal antibody or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer)
- Has an active infection requiring systemic therapy
- Has known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
- Has known history of or is positive for Hepatitis B or Hepatitis C
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Incyte Corporationlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (129)
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Birmingham, Alabama, United States
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Scottsdale, Arizona, United States
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Little Rock, Arkansas, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Santa Barbara, California, United States
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Santa Monica, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Ocala, Florida, United States
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West Palm Beach, Florida, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Lutherville, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Fridley, Minnesota, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Fairfax, Virginia, United States
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Spokane, Washington, United States
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Camperdown, New South Wales, Australia
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Westmead, New South Wales, Australia
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Wollstonecraft, New South Wales, Australia
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Cairns, Queensland, Australia
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Greenslopes, Queensland, Australia
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Kurralta Park, South Australia, Australia
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Melbourne, Victoria, Australia
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Brussels, Belgium
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Ghent, Belgium
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North Vancouver, British Columbia, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Santiago, Chile
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Viña del Mar, Chile
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Aarhus, Denmark
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Herlev, Denmark
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Odense C, Denmark
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Bordeaux, France
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Lille, France
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Marseille, France
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Paris, France
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Pierre-Bénite, France
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Reims, France
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Rennes, France
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Toulouse, France
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Villejuif, France
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Buxtehude, Germany
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Essen, Germany
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Hanover, Germany
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Kiel, Germany
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Tübingen, Germany
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Cork, Ireland
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Dublin, Ireland
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Galway, Ireland
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Ramat Gan, Israel
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Bergamo, Italy
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Genova, Italy
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Milan, Italy
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Napoli, Italy
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Padua, Italy
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Siena, Italy
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Susono, Sunto-gun, Japan
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Asahikawa, Japan
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Chūō, Japan
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Fukuoka, Japan
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Kagoshima, Japan
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Kumamoto, Japan
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Kurume, Japan
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Kyoto, Japan
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Matsumoto, Japan
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Nagoya, Japan
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Niigata, Japan
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Okayama, Japan
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Osaka, Japan
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Sapporo, Japan
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Sendai, Japan
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Tokyo, Japan
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Tsukuba, Japan
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Chihuahua City, Mexico
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Distrito Federal, Mexico
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Mexico City, Mexico
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Monterrey, Mexico
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Amsterdam, Netherlands
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Nijmegen, Netherlands
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Dunedin, New Zealand
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Tauranga, New Zealand
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Warsaw, Poland
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Istra, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Johannesburg, Gauteng, South Africa
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Sandton, Gauteng, South Africa
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Groenkloof, Pretoria, South Africa
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Cape Town, Western Cape, South Africa
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Kraaifontein, South Africa
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Seoul, South Korea
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Donostia / San Sebastian, Guipuzcoa, Spain
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A Coruña, Spain
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Barcelona, Spain
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Donostia / San Sebastian, Spain
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Madrid, Spain
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Pamplona, Spain
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Seville, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
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Zurich, Canton of Zurich, Switzerland
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Geneva, Switzerland
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Lausanne, Switzerland
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Edinburgh, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
Related Publications (1)
Long GV, Dummer R, Hamid O, Gajewski TF, Caglevic C, Dalle S, Arance A, Carlino MS, Grob JJ, Kim TM, Demidov L, Robert C, Larkin J, Anderson JR, Maleski J, Jones M, Diede SJ, Mitchell TC. Epacadostat plus pembrolizumab versus placebo plus pembrolizumab in patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252): a phase 3, randomised, double-blind study. Lancet Oncol. 2019 Aug;20(8):1083-1097. doi: 10.1016/S1470-2045(19)30274-8. Epub 2019 Jun 17.
PMID: 31221619DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Mark Jones, MD
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2016
First Posted
April 26, 2016
Study Start
June 21, 2016
Primary Completion
January 8, 2018
Study Completion
August 16, 2019
Last Updated
August 24, 2025
Results First Posted
May 15, 2019
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share