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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 January 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: January 17, 2017
Last verified: January 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: Double Blind (Subject, Caregiver, 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
Not yet recruiting
Birmingham, Alabama, United States
United States, Arizona
Not yet recruiting
Scottsdale, Arizona, United States
United States, Arkansas
Not yet recruiting
Little Rock, Arkansas, United States
United States, California
Recruiting
Los Angeles, California, United States
Not yet recruiting
San Francisco, California, United States
Recruiting
Santa Barbara, California, United States
Recruiting
Santa Monica, California, United States
United States, Colorado
Recruiting
Aurora, Colorado, United States
Not yet recruiting
Denver, Colorado, United States
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States
United States, Florida
Recruiting
Fort Lauderdale, Florida, United States
Not yet recruiting
Jacksonville, Florida, United States
Not yet recruiting
Ocala, Florida, United States
Recruiting
West Palm Beach, Florida, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
Recruiting
Peoria, Illinois, United States
United States, Iowa
Recruiting
Iowa City, Iowa, United States
United States, Kansas
Not yet recruiting
Kansas City, Kansas, United States
United States, Maryland
Recruiting
Lutherville, Maryland, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States
United States, Minnesota
Recruiting
Fridley, Minnesota, United States
United States, Montana
Recruiting
Billings, Montana, United States
United States, Nebraska
Recruiting
Omaha, Nebraska, United States
United States, Nevada
Recruiting
Las Vegas, Nevada, United States
United States, New York
Recruiting
Rochester, New York, United States
United States, North Carolina
Not yet recruiting
Charlotte, North Carolina, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States
United States, Tennessee
Recruiting
Nashville, Tennessee, United States
United States, Texas
Recruiting
Austin, Texas, United States
Recruiting
Dallas, Texas, United States
United States, Utah
Recruiting
Salt Lake City, Utah, United States
United States, Virginia
Recruiting
Fairfax, Virginia, United States
United States, Washington
Recruiting
Spokane, Washington, United States
Australia, New South Wales
Recruiting
Camperdown, New South Wales, Australia
Australia, Queensland
Recruiting
Cairns, Queensland, Australia
Recruiting
Greenslopes, Queensland, Australia
Australia
Recruiting
Kurralta Park, Australia
Recruiting
Melbourne, Australia
Recruiting
Westmead, Australia
Recruiting
Wollstonecraft, Australia
Belgium
Recruiting
Brussels, Belgium
Not yet recruiting
Gent, Belgium
Canada, British Columbia
Recruiting
North Vancouver, British Columbia, Canada
Canada, Ontario
Recruiting
Ottawa, Ontario, Canada
Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
Chile
Recruiting
Santiago, Chile
Recruiting
Vina del Mar, Chile
Denmark
Not yet recruiting
Aarhus, Denmark
Recruiting
Herlev, Denmark
Recruiting
Odense C, Denmark
France
Recruiting
Bordeaux, France
Recruiting
Lille, France
Recruiting
Marseille, France
Recruiting
Paris, France
Recruiting
Pierre Benite, France
Recruiting
Reims, France
Recruiting
Rennes, France
Recruiting
Toulouse, France
Recruiting
Villejuif, France
Germany
Recruiting
Buxtehude, Germany
Recruiting
Essen, Germany
Recruiting
Hannover, Germany
Recruiting
Kiel, Germany
Recruiting
Tuebingen, Germany
Ireland
Recruiting
Cork, Ireland
Recruiting
Dublin, Ireland
Recruiting
Galway, Ireland
Israel
Recruiting
Ramat Gan, Israel
Italy
Recruiting
Bergamo, Italy
Recruiting
Genova, Italy
Recruiting
Milano, Italy
Recruiting
Napoli, Italy
Recruiting
Padova, Italy
Recruiting
Siena, Italy
Japan
Not yet recruiting
Asahikawa, Japan
Not yet recruiting
Chuo, Japan
Not yet recruiting
Fukuoka, Japan
Not yet recruiting
Kagoshima, Japan
Not yet recruiting
Kumamoto, Japan
Not yet recruiting
Kurume, Japan
Not yet recruiting
Matsumoto, Japan
Not yet recruiting
Nagoya, Japan
Not yet recruiting
Niigata, Japan
Not yet recruiting
Okayama, Japan
Not yet recruiting
Osaka, Japan
Not yet recruiting
Sapporo, Japan
Not yet recruiting
Sendai, Japan
Not yet recruiting
Sunto-gun, Japan
Not yet recruiting
Tokyo, Japan
Not yet recruiting
Tsukuba, Japan
Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Mexico
Not yet recruiting
Chihuahua, Mexico
Not yet recruiting
Mexico City, Mexico
Recruiting
Mexico D.F., Mexico
Not yet recruiting
Monterrey, Mexico
Netherlands
Recruiting
Amsterdam, Netherlands
Recruiting
Nijmegen, Netherlands
New Zealand
Recruiting
Dunedin, New Zealand
Recruiting
Tauranga, New Zealand
Poland
Recruiting
Warszawa, Poland
Russian Federation
Recruiting
Istra village, Russian Federation
Recruiting
Moscow, Russian Federation
Recruiting
Saint Petersburg, Russian Federation
South Africa
Recruiting
Johannesburg, Gauteng, South Africa
Recruiting
Sandton, Gauteng, South Africa
Recruiting
Groenkloof, Pretoria, South Africa
Recruiting
Cape Town, Western Cape, South Africa
Recruiting
Kraaifontein, South Africa
Spain
Recruiting
Donostia-San Sebastian, Guipuzcoa, Spain
Not yet recruiting
A Coruna, Spain
Recruiting
Barcelona, Spain
Recruiting
Madrid, Spain
Not yet recruiting
Pamplona, Spain
Recruiting
San Sebastian, Spain
Recruiting
Sevilla, Spain
Recruiting
Valencia, Spain
Sweden
Recruiting
Göteborg, Sweden
Recruiting
Lund, Sweden
Recruiting
Stockholm, Sweden
Recruiting
Uppsala, Sweden
Switzerland
Recruiting
Zürich, ZH, Switzerland
Recruiting
Geneve, Switzerland
Recruiting
Lausanne, Switzerland
United Kingdom
Recruiting
Edinburgh, United Kingdom
Recruiting
London, United Kingdom
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: January 17, 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 March 27, 2017