Melanoma Clinical Trial
A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)
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
Eligibility 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
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There is 1 Location for this study
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 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
Gent , , Belgium
North Vancouver British Columbia, , Canada
Ottawa Ontario, , Canada
Toronto Ontario, , Canada
Montreal Quebec, , Canada
Santiago , , Chile
Vina del Mar , , Chile
Aarhus , , Denmark
Herlev , , Denmark
Odense C , , Denmark
Bordeaux , , France
Lille , , France
Marseille , , France
Paris , , France
Pierre Benite , , France
Reims , , France
Rennes , , France
Toulouse , , France
Villejuif , , France
Buxtehude , , Germany
Essen , , Germany
Hannover , , Germany
Kiel , , Germany
Tuebingen , , Germany
Cork , , Ireland
Dublin , , Ireland
Galway , , Ireland
Ramat Gan , , Israel
Bergamo , , Italy
Genova , , Italy
Milano , , Italy
Napoli , , Italy
Padova , , Italy
Siena , , Italy
Susono Sunto-gun, , 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
Tokyo , , Japan
Tsukuba , , Japan
Seoul , , Korea, Republic of
Chihuahua , , Mexico
Distrito Federal , , Mexico
Mexico City , , Mexico
Monterrey , , Mexico
Amsterdam , , Netherlands
Nijmegen , , Netherlands
Dunedin , , New Zealand
Tauranga , , New Zealand
Warszawa , , Poland
Istra , , Russian Federation
Moscow , , Russian Federation
Saint Petersburg , , Russian Federation
Johannesburg Gauteng, , South Africa
Sandton Gauteng, , South Africa
Groenkloof Pretoria, , South Africa
Cape Town Western Cape, , South Africa
Kraaifontein , , South Africa
Donostia-San Sebastian Guipuzcoa, , Spain
A Coruna , , Spain
Barcelona , , Spain
Madrid , , Spain
Pamplona , , Spain
San Sebastian , , Spain
Sevilla , , Spain
Valencia , , Spain
Göteborg , , Sweden
Lund , , Sweden
Stockholm , , Sweden
Uppsala , , Sweden
Zürich ZH, , Switzerland
Geneve , , Switzerland
Lausanne , , Switzerland
Edinburgh , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
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