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

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Incyte Corporation
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02752074
First received: April 22, 2016
Last updated: April 14, 2017
Last verified: April 2017
  Purpose
The purpose of the study is to assess the efficacy, safety, and tolerability when combining pembrolizumab with epacadostat or placebo in subjects with unresectable or metastatic melanoma

Condition Intervention Phase
Melanoma Drug: pembrolizumab + epacadostat Drug: pembrolizumab + placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 24 months ]
    Defined as time from date of randomization until the earliest date of disease progression per RECIST 1.1, or death from any cause, whichever comes first.

  • Overall survival [ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 24 months ]
    Defined as time from date of randomization to date of death due to any cause.


Secondary Outcome Measures:
  • Objective response rate [ Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 24 months ]
    Defined as the proportion of subjects who have best response as complete response or partial response based on RECIST 1.1.

  • Safety and tolerability, as assessed by percentage of subjects with adverse events [ Time Frame: Through up to 90 days after end of treatment, up to 27 months ]
  • Safety and tolerability, as assessed by percentage of subjects with changes in laboratory parameters [ Time Frame: Through up to 90 days after end of treatment, up to 27 months ]

Estimated Enrollment: 600
Study Start Date: June 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pembrolizumab + Epacadostat
Pembrolizumab + Epacadostat
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)
Active Comparator: Pembrolizumab + Placebo
Pembrolizumab + Placebo
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)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02752074

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

  Hide Study Locations
Locations
United States, Alabama
Active, not recruiting
Birmingham, Alabama, United States
United States, Arizona
Active, not recruiting
Scottsdale, Arizona, United States
United States, Arkansas
Active, not recruiting
Little Rock, Arkansas, United States
United States, California
Active, not recruiting
Los Angeles, California, United States
Active, not recruiting
San Francisco, California, United States
Active, not recruiting
Santa Barbara, California, United States
Active, not recruiting
Santa Monica, California, United States
United States, Colorado
Active, not recruiting
Aurora, Colorado, United States
Active, not recruiting
Denver, Colorado, United States
United States, District of Columbia
Active, not recruiting
Washington, District of Columbia, United States
United States, Florida
Active, not recruiting
Fort Lauderdale, Florida, United States
Active, not recruiting
Jacksonville, Florida, United States
Active, not recruiting
Ocala, Florida, United States
Active, not recruiting
West Palm Beach, Florida, United States
United States, Illinois
Active, not recruiting
Chicago, Illinois, United States
Active, not recruiting
Peoria, Illinois, United States
United States, Iowa
Active, not recruiting
Iowa City, Iowa, United States
United States, Kansas
Active, not recruiting
Kansas City, Kansas, United States
United States, Maryland
Active, not recruiting
Lutherville, Maryland, United States
United States, Massachusetts
Active, not recruiting
Boston, Massachusetts, United States
United States, Michigan
Active, not recruiting
Ann Arbor, Michigan, United States
United States, Minnesota
Active, not recruiting
Fridley, Minnesota, United States
United States, Montana
Active, not recruiting
Billings, Montana, United States
United States, Nebraska
Active, not recruiting
Omaha, Nebraska, United States
United States, Nevada
Active, not recruiting
Las Vegas, Nevada, United States
United States, New York
Active, not recruiting
Rochester, New York, United States
United States, North Carolina
Active, not recruiting
Charlotte, North Carolina, United States
United States, Pennsylvania
Active, not recruiting
Philadelphia, Pennsylvania, United States
United States, Tennessee
Active, not recruiting
Nashville, Tennessee, United States
United States, Texas
Active, not recruiting
Austin, Texas, United States
Active, not recruiting
Dallas, Texas, United States
United States, Utah
Active, not recruiting
Salt Lake City, Utah, United States
United States, Virginia
Active, not recruiting
Fairfax, Virginia, United States
United States, Washington
Active, not recruiting
Spokane, Washington, United States
Australia, New South Wales
Active, not recruiting
Camperdown, New South Wales, Australia
Australia, Queensland
Active, not recruiting
Cairns, Queensland, Australia
Active, not recruiting
Greenslopes, Queensland, Australia
Australia
Active, not recruiting
Kurralta Park, Australia
Active, not recruiting
Melbourne, Australia
Active, not recruiting
Westmead, Australia
Active, not recruiting
Wollstonecraft, Australia
Belgium
Active, not recruiting
Brussels, Belgium
Active, not recruiting
Gent, Belgium
Canada, British Columbia
Active, not recruiting
North Vancouver, British Columbia, Canada
Canada, Ontario
Active, not recruiting
Ottawa, Ontario, Canada
Active, not recruiting
Toronto, Ontario, Canada
Canada, Quebec
Active, not recruiting
Montreal, Quebec, Canada
Chile
Active, not recruiting
Santiago, Chile
Active, not recruiting
Vina del Mar, Chile
Denmark
Active, not recruiting
Aarhus, Denmark
Active, not recruiting
Herlev, Denmark
Active, not recruiting
Odense C, Denmark
France
Active, not recruiting
Bordeaux, France
Active, not recruiting
Lille, France
Active, not recruiting
Marseille, France
Active, not recruiting
Paris, France
Active, not recruiting
Pierre Benite, France
Active, not recruiting
Reims, France
Active, not recruiting
Rennes, France
Active, not recruiting
Toulouse, France
Active, not recruiting
Villejuif, France
Germany
Active, not recruiting
Buxtehude, Germany
Active, not recruiting
Essen, Germany
Active, not recruiting
Hannover, Germany
Active, not recruiting
Kiel, Germany
Active, not recruiting
Tuebingen, Germany
Ireland
Active, not recruiting
Cork, Ireland
Active, not recruiting
Dublin, Ireland
Active, not recruiting
Galway, Ireland
Israel
Active, not recruiting
Ramat Gan, Israel
Italy
Active, not recruiting
Bergamo, Italy
Active, not recruiting
Genova, Italy
Active, not recruiting
Milano, Italy
Active, not recruiting
Napoli, Italy
Active, not recruiting
Padova, Italy
Active, not recruiting
Siena, Italy
Japan
Recruiting
Asahikawa, Japan
Recruiting
Chuo, Japan
Recruiting
Fukuoka, Japan
Recruiting
Kagoshima, Japan
Recruiting
Kumamoto, Japan
Recruiting
Kurume, Japan
Not yet recruiting
Kyoto, Japan
Recruiting
Matsumoto, Japan
Recruiting
Nagoya, Japan
Recruiting
Niigata, Japan
Recruiting
Okayama, Japan
Not yet recruiting
Osaka, Japan
Recruiting
Sapporo, Japan
Recruiting
Sendai, Japan
Recruiting
Sunto-gun, Japan
Recruiting
Tokyo, Japan
Recruiting
Tsukuba, Japan
Korea, Republic of
Active, not recruiting
Seoul, Korea, Republic of
Mexico
Active, not recruiting
Chihuahua, Mexico
Active, not recruiting
Mexico City, Mexico
Active, not recruiting
Mexico D.F., Mexico
Active, not recruiting
Monterrey, Mexico
Netherlands
Active, not recruiting
Amsterdam, Netherlands
Active, not recruiting
Nijmegen, Netherlands
New Zealand
Active, not recruiting
Dunedin, New Zealand
Active, not recruiting
Tauranga, New Zealand
Poland
Active, not recruiting
Warszawa, Poland
Russian Federation
Active, not recruiting
Istra village, Russian Federation
Active, not recruiting
Moscow, Russian Federation
Active, not recruiting
Saint Petersburg, Russian Federation
South Africa
Active, not recruiting
Johannesburg, Gauteng, South Africa
Active, not recruiting
Sandton, Gauteng, South Africa
Active, not recruiting
Groenkloof, Pretoria, South Africa
Active, not recruiting
Cape Town, Western Cape, South Africa
Active, not recruiting
Kraaifontein, South Africa
Spain
Active, not recruiting
Donostia-San Sebastian, Guipuzcoa, Spain
Active, not recruiting
A Coruna, Spain
Active, not recruiting
Barcelona, Spain
Active, not recruiting
Madrid, Spain
Active, not recruiting
Pamplona, Spain
Active, not recruiting
San Sebastian, Spain
Active, not recruiting
Sevilla, Spain
Active, not recruiting
Valencia, Spain
Sweden
Active, not recruiting
Göteborg, Sweden
Active, not recruiting
Lund, Sweden
Active, not recruiting
Stockholm, Sweden
Active, not recruiting
Uppsala, Sweden
Switzerland
Active, not recruiting
Zürich, ZH, Switzerland
Active, not recruiting
Geneve, Switzerland
Active, not recruiting
Lausanne, Switzerland
United Kingdom
Active, not recruiting
Edinburgh, United Kingdom
Active, not recruiting
London, United Kingdom
Active, not recruiting
Manchester, United Kingdom
Sponsors and Collaborators
Incyte Corporation
Merck Sharp & Dohme Corp.
Investigators
Study Director: Mark Jones, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02752074     History of Changes
Other Study ID Numbers: INCB 24360-301 (ECHO-301)
Study First Received: April 22, 2016
Last Updated: April 14, 2017

Keywords provided by Incyte Corporation:
Melanoma
Metastatic Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2017