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Brief Title: Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067)
Official Title: A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
Study ID: NCT01844505
Brief Summary: The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 0085, Gilbert, Arizona, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
Local Institution - 0046, La Jolla, California, United States
Local Institution - 0053, Los Angeles, California, United States
Local Institution - 0014, Los Angeles, California, United States
Comprehensive Cancer Center At Desert Regional Medical Ctr, Palm Springs, California, United States
Local Institution - 0066, Rancho Mirage, California, United States
California Pacific Medical Center Research Institute, San Francisco, California, United States
Local Institution - 0049, San Francisco, California, United States
Local Institution - 0052, Aurora, Colorado, United States
Local Institution - 0084, New Haven, Connecticut, United States
Local Institution - 0098, Washington, District of Columbia, United States
Local Institution - 0183, Washington, District of Columbia, United States
Local Institution - 0042, Jacksonville, Florida, United States
Local Institution - 0008, Orlando, Florida, United States
Local Institution - 0051, Atlanta, Georgia, United States
Maine Center For Cancer Medicine, Scarborough, Maine, United States
Local Institution - 0080, Lutherville, Maryland, United States
Local Institution - 0081, Boston, Massachusetts, United States
Local Institution - 0082, Boston, Massachusetts, United States
Local Institution - 0083, Boston, Massachusetts, United States
Local Institution - 0087, Ann Arbor, Michigan, United States
Local Institution - 0187, Minneapolis, Minnesota, United States
Local Institution - 0065, Jackson, Mississippi, United States
Local Institution - 0067, Saint Louis, Missouri, United States
Local Institution - 0015, Las Vegas, Nevada, United States
Local Institution - 0188, Morristown, New Jersey, United States
Local Institution - 0068, Albuquerque, New Mexico, United States
Local Institution - 0079, Albany, New York, United States
Local Institution - 0174, New York, New York, United States
Local Institution - 0070, New York, New York, United States
Local Institution - 0047, Charlotte, North Carolina, United States
Local Institution - 0048, Durham, North Carolina, United States
Local Institution - 0007, Cleveland, Ohio, United States
Local Institution - 0045, Portland, Oregon, United States
Local Institution - 0061, Allentown, Pennsylvania, United States
Local Institution - 0112, Bethlehem, Pennsylvania, United States
Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Local Institution - 0154, Greenville, South Carolina, United States
Local Institution - 0062, Nashville, Tennessee, United States
Local Institution - 0064, Nashville, Tennessee, United States
Local Institution - 0044, Dallas, Texas, United States
Texas Oncology, Dallas, Texas, United States
Local Institution - 0088, Houston, Texas, United States
Local Institution - 0089, Salt Lake City, Utah, United States
Local Institution - 0054, Seattle, Washington, United States
Local Institution - 0017, Camperdown, New South Wales, Australia
Local Institution - 0031, Coffs Harbour, New South Wales, Australia
Local Institution - 0028, Gateshead, New South Wales, Australia
Local Institution - 0023, Macquarie University, New South Wales, Australia
Local Institution - 0138, North Sydney, New South Wales, Australia
Local Institution - 0019, Brisbane, Queensland, Australia
Local Institution - 0022, Southport, Queensland, Australia
Local Institution - 0018, Woolloongabba, Queensland, Australia
Local Institution - 0020, Adelaide, South Australia, Australia
Local Institution - 0025, Kurralta Park, South Australia, Australia
Local Institution - 0024, Box Hill, Victoria, Australia
Local Institution - 0016, Heidelberg, Victoria, Australia
Local Institution - 0026, Melbourne, Victoria, Australia
Local Institution - 0021, Nedlands, Western Australia, Australia
Local Institution - 0148, Salzburg, , Austria
Local Institution - 0145, Wien, , Austria
Local Institution - 0003, Brussels, , Belgium
Local Institution - 0002, Bruxelles, , Belgium
Local Institution - 0004, Edegem, , Belgium
Local Institution - 0005, Gent, , Belgium
Local Institution - 0103, Leuven, , Belgium
Local Institution - 0140, Edmonton, Alberta, Canada
Local Institution - 0165, Vancouver, British Columbia, Canada
Local Institution - 0141, London, Ontario, Canada
Local Institution - 0143, Ottawa, Ontario, Canada
Local Institution - 0166, Toronto, Ontario, Canada
Local Institution - 0139, Montreal, Quebec, Canada
Local Institution - 0142, Quebec City, Quebec, Canada
Local Institution - 0092, Brno, , Czechia
Local Institution - 0091, Hradec Kralove, , Czechia
Local Institution - 0090, Praha 2, , Czechia
Local Institution - 0167, Praha 8, , Czechia
Local Institution - 0076, Aarhus, , Denmark
Local Institution - 0078, Herlev, , Denmark
Local Institution - 0077, Odense, , Denmark
Local Institution - 0071, Helsinki, Uusimaa, Finland
Local Institution - 0169, Tampere, , Finland
Local Institution - 0125, Boulogne Billancourt, , France
Local Institution - 0126, Marseille Cedex 5, , France
Local Institution - 0056, Nantes Cedex, , France
Local Institution - 0058, Paris Cedex 10, , France
Local Institution - 0124, Pierre Benite, , France
Local Institution - 0127, Rennes, , France
Local Institution, Villejuif, , France
Local Institution - 0162, Buxtehude, , Germany
Local Institution - 0161, Erfurt, , Germany
Local Institution - 0171, Erlangen, , Germany
Local Institution - 0156, Essen, , Germany
Local Institution - 0159, Hannover, , Germany
Local Institution - 0157, Heidelberg, , Germany
Local Institution - 0158, Kiel, , Germany
Local Institution - 0178, Leipzig, , Germany
Local Institution - 0160, Munchen, , Germany
Local Institution - 0134, Tuebingen, , Germany
Local Institution - 0035, Dublin 9, Dublin, Ireland
Local Institution - 0033, Cork, , Ireland
Local Institution - 0168, Dublin, , Ireland
Local Institution - 0036, Dublin, , Ireland
Local Institution - 0034, Dublin, , Ireland
Local Institution - 0032, Galway, , Ireland
Local Institution - 0120, Jerusalem, , Israel
Local Institution - 0121, Tel Hashomer, , Israel
Local Institution - 0176, Bergamo, , Italy
Local Institution - 0115, Genova, , Italy
Local Institution - 0113, Meldola (FC), , Italy
Local Institution - 0172, Milano, , Italy
Local Institution - 0117, Milano, , Italy
Local Institution - 0114, Napoli, , Italy
Local Institution - 0118, Padova, , Italy
Local Institution - 0177, Roma, , Italy
Local Institution - 0116, Siena, , Italy
Local Institution - 0010, Amsterdam, , Netherlands
Local Institution - 0012, Leiden, , Netherlands
Local Institution - 0013, Nijmegen, , Netherlands
Local Institution - 0029, Auckland, , New Zealand
Local Institution - 0123, Oslo, , Norway
Local Institution - 0109, Gdansk, , Poland
Local Institution - 0133, Krakow, , Poland
Local Institution - 0060, Lodz, , Poland
Local Institution - 0059, Warszawa, , Poland
Local Institution - 0130, Moscow, , Russian Federation
Local Institution - 0132, Saint Petersburg, , Russian Federation
Local Institution - 0131, Samara, , Russian Federation
Local Institution - 0128, St. Petersburg, , Russian Federation
Local Institution - 0152, Badalona-Barcelona, , Spain
Local Institution - 0151, Barcelona, , Spain
Local Institution - 0175, Barcelona, , Spain
Local Institution - 0150, Madrid, , Spain
Local Institution - 0149, Madrid, , Spain
Local Institution - 0153, Malaga, , Spain
Local Institution - 0147, Pamplona, , Spain
Local Institution - 0182, Gothenberg, , Sweden
Local Institution - 0184, Stockholm, , Sweden
Local Institution - 0164, Geneva, , Switzerland
Local Institution - 0189, Lausanne, , Switzerland
Local Institution - 0186, St. Gallen, , Switzerland
Local Institution - 0163, Zuerich, , Switzerland
Local Institution - 0039, Glasgow, Dumfries & Galloway, United Kingdom
Local Institution - 0038, London, Greater London, United Kingdom
Local Institution - 0119, Manchester, Greater Manchester, United Kingdom
Local Institution - 0041, Northwood, Middlesex, United Kingdom
Local Institution - 0122, Nottingham, Nottinghamshire, United Kingdom
Local Institution - 0037, Cambridge, , United Kingdom
Local Institution - 0040, Swansea, , United Kingdom
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR