A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
NCT ID: NCT02752074
Last Updated: 2025-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
706 participants
INTERVENTIONAL
2016-06-21
2019-08-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pembrolizumab + Epacadostat
Pembrolizumab + Epacadostat
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)
Pembrolizumab + Placebo
Pembrolizumab + Placebo
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)
Interventions
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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)
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)
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Jones, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Santa Monica, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Ocala, Florida, United States
West Palm Beach, Florida, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Lutherville, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Fridley, Minnesota, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Spokane, Washington, United States
Camperdown, New South Wales, Australia
Westmead, New South Wales, Australia
Wollstonecraft, New South Wales, Australia
Cairns, Queensland, Australia
Greenslopes, Queensland, Australia
Kurralta Park, South Australia, Australia
Melbourne, Victoria, Australia
Brussels, , Belgium
Ghent, , Belgium
North Vancouver, British Columbia, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Santiago, , Chile
Viña del Mar, , Chile
Aarhus, , Denmark
Herlev, , Denmark
Odense C, , Denmark
Bordeaux, , France
Lille, , France
Marseille, , France
Paris, , France
Pierre-Bénite, , France
Reims, , France
Rennes, , France
Toulouse, , France
Villejuif, , France
Buxtehude, , Germany
Essen, , Germany
Hanover, , Germany
Kiel, , Germany
Tübingen, , Germany
Cork, , Ireland
Dublin, , Ireland
Galway, , Ireland
Ramat Gan, , Israel
Bergamo, , Italy
Genova, , Italy
Milan, , Italy
Napoli, , Italy
Padua, , Italy
Siena, , Italy
Susono, Sunto-gun, Japan
Asahikawa, , Japan
Chūō, , Japan
Fukuoka, , Japan
Kagoshima, , Japan
Kumamoto, , Japan
Kurume, , Japan
Kyoto, , Japan
Matsumoto, , Japan
Nagoya, , Japan
Niigata, , Japan
Okayama, , Japan
Osaka, , Japan
Sapporo, , Japan
Sendai, , Japan
Tokyo, , Japan
Tsukuba, , Japan
Chihuahua City, , Mexico
Distrito Federal, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Amsterdam, , Netherlands
Nijmegen, , Netherlands
Dunedin, , New Zealand
Tauranga, , New Zealand
Warsaw, , Poland
Istra, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Johannesburg, Gauteng, South Africa
Sandton, Gauteng, South Africa
Groenkloof, Pretoria, South Africa
Cape Town, Western Cape, South Africa
Kraaifontein, , South Africa
Seoul, , South Korea
Donostia / San Sebastian, Guipuzcoa, Spain
A Coruña, , Spain
Barcelona, , Spain
Donostia / San Sebastian, , Spain
Madrid, , Spain
Pamplona, , Spain
Seville, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Lund, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Zurich, Canton of Zurich, Switzerland
Geneva, , Switzerland
Lausanne, , Switzerland
Edinburgh, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-004991-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 24360-301 (ECHO-301)
Identifier Type: -
Identifier Source: org_study_id
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