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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02752074
Recruitment Status : Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Melanoma Drug: pembrolizumab + epacadostat Drug: pembrolizumab + placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 706 participants
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)
Study Start Date : June 2016
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.

  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752074


  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Scottsdale, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Los Angeles, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Santa Monica, California, United States
United States, Colorado
Aurora, Colorado, United States
Denver, Colorado, United States
United States, District of Columbia
Washington, D.C., District of Columbia, United States
United States, Florida
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Ocala, Florida, United States
West Palm Beach, Florida, United States
United States, Illinois
Chicago, Illinois, United States
Peoria, Illinois, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Maryland
Lutherville, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, Minnesota
Fridley, Minnesota, United States
United States, Montana
Billings, Montana, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Rochester, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Fairfax, Virginia, United States
United States, Washington
Spokane, Washington, United States
Australia, New South Wales
Camperdown, New South Wales, Australia
Australia, Queensland
Cairns, Queensland, Australia
Greenslopes, Queensland, Australia
Australia
Kurralta Park, Australia
Melbourne, Australia
Westmead, Australia
Wollstonecraft, Australia
Belgium
Brussels, Belgium
Gent, Belgium
Canada, British Columbia
North Vancouver, British Columbia, Canada
Canada, Ontario
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Chile
Santiago, Chile
Vina del Mar, Chile
Denmark
Aarhus, Denmark
Herlev, Denmark
Odense C, Denmark
France
Bordeaux, France
Lille, France
Marseille, France
Paris, France
Pierre Benite, France
Reims, France
Rennes, France
Toulouse, France
Villejuif, France
Germany
Buxtehude, Germany
Essen, Germany
Hannover, Germany
Kiel, Germany
Tuebingen, Germany
Ireland
Cork, Ireland
Dublin, Ireland
Galway, Ireland
Israel
Ramat Gan, Israel
Italy
Bergamo, Italy
Genova, Italy
Milano, Italy
Napoli, Italy
Padova, Italy
Siena, Italy
Japan
Asahikawa, Japan
Chuo, 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
Sunto-gun, Japan
Tokyo, Japan
Tsukuba, Japan
Korea, Republic of
Seoul, Korea, Republic of
Mexico
Chihuahua, Mexico
Mexico City, Mexico
Mexico D.F., Mexico
Monterrey, Mexico
Netherlands
Amsterdam, Netherlands
Nijmegen, Netherlands
New Zealand
Dunedin, New Zealand
Tauranga, New Zealand
Poland
Warszawa, Poland
Russian Federation
Istra village, Russian Federation
Moscow, Russian Federation
Saint Petersburg, Russian Federation
South Africa
Johannesburg, Gauteng, South Africa
Sandton, Gauteng, South Africa
Groenkloof, Pretoria, South Africa
Cape Town, Western Cape, South Africa
Kraaifontein, South Africa
Spain
Donostia-San Sebastian, Guipuzcoa, Spain
A Coruna, Spain
Barcelona, Spain
Madrid, Spain
Pamplona, Spain
San Sebastian, Spain
Sevilla, Spain
Valencia, Spain
Sweden
Göteborg, Sweden
Lund, Sweden
Stockholm, Sweden
Uppsala, Sweden
Switzerland
Zürich, ZH, Switzerland
Geneve, Switzerland
Lausanne, Switzerland
United Kingdom
Edinburgh, United Kingdom
London, United Kingdom
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)
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 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