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

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

706

Study ID:

NCT02752074

Recruitment Status:

Completed

Sponsor:

Incyte Corporation

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There is 1 Location for this study

See Locations Near You


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

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

706

Study ID:

NCT02752074

Recruitment Status:

Completed

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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